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Spectral AI, Inc.

$1.65

+0.03 (+2.17%)

Market Cap
85.29 M
EPS
-0.53
P/E Ratio
-
Value Trade
1.42 M
SEC Financials
Q1 2026
  • Dilution Risk

    60%
  • Revenue

    3.99 M

  • R&D Expenses

    2.00 M

  • Operating CF

    -3.73 M


  • Total Assets

    17.73 M

  • Total Liabilities

    26.54 M

  • Equity

    -8.81 M

27.62 %
Week
45.65 %
1 Month
82.31 %
3 Month
94.2 %
6 Month
-72.14 %
5 Year
-72.26 %
All Time
Cash Data
Caution
  • Cash Position

    11.70 M

  • Monthly Burn

    1.24 M

  • Runway

    6.9 mo

  • Burn Trend

    Accelerating
  • SEC Filing

    May 13, 2026
Overview
Volume
113.01 K
52 Week Range
1.18 - 3.21
% held by Insiders
15.77 %
% held by Institutions
7.58 %
Enterprise Value
83.57 M
Total Shares
31.84 M
Short %
9.77 %
Float Shares
24.67 M
Company Description
HQ: 2515 MCKINNEY AVE #1000, DALLA...
Employees:65

locked

Upcoming Catalyst
Catalyst Drug/Treatment Stage Probability of Approval Description Drug Type Therapeutic Area Source
Example Drug Treatment for example condition requiring FDA review
Phase 3
-%

FDA review of the new drug application for the treatment of example condition.

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Small Molecule
Oncology
Example Drug Treatment for example condition requiring FDA review
Phase 3
-%

FDA review of the new drug application for the treatment of example condition.

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Small Molecule
Oncology
Example Drug Treatment for example condition requiring FDA review
Phase 3
-%

FDA review of the new drug application for the treatment of example condition.

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Small Molecule
Oncology
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Past FDA Catalysts & PDUFA Decisions
Date Drug Catalyst Stage Outcome Reaction Event Move % Best Trade %
Example Drug
Phase 3 data readout
Phase 3
0%
0%
Example Drug
Phase 3 data readout
Phase 3
0%
0%
Example Drug
Phase 3 data readout
Phase 3
0%
0%
Unlock Historical Catalyst data
Drug Pipeline Intelligence
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Clinical Trial Results
Drug Name Indications Phase Date Trial Results Summary Title Source
DeepView System
Breakthrough
burn care
2025-06-10

increasing detection rates from 61% to 89% (p < 0.0001)

DeepView® System highlighted at the annual British Burn Association conference

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DeepView System
Breakthrough
burn care
2025-06-10

increasing detection rates from 61% to 89% (p < 0.0001)

DeepView® System highlighted at the annual British Burn Association conference

Read More
DeepView System
Breakthrough
burn care
2025-06-10

increasing detection rates from 61% to 89% (p < 0.0001)

DeepView® System highlighted at the annual British Burn Association conference

Read More
Unlock Clinical Trial Results data
Inside Trades
TREND
CORPORATE INSIDERS BOUGHT SHARES WORTH 1.8M IN THE LAST 3 MONTHS
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLD
INSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Unlock Inside Trades data
Hedge Funds
TREND
HEDGE FUNDS INCREASED HOLDINGS BY 200.0K SHARES IN THE LAST QUARTER
Shares Held
2040.00B1530.00B1020.00B510.00B0
Q3
2024
Q4
2024
Q1
2025
Q2
2025
HEDGE FUNDS
SOLD
HEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Fund Count
60%
Share Volume
25%
Conviction
15%
HedgeFund Name
( 3 )
% of Portfolio Current MV
-
Shares Owned
-
Activity
Avg Price $0

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K
Unlock Hedge Funds table data
MDAI Institutional Ownership Trends
Current Insider %
5.20%
+0.00%
Current Institutional %
62.40%
+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
ExpirationVolumeOpen InterestImplied Volatility CallsImplied Volatility Puts
CallsPutsPut-Call RatioCallsPutsPut-Call RatioIVOiWaIvVWaIvIVOiWaIvVWaIv
Unlock Option Chain Statistics data
Option Chain
CallsStrikePuts
Last PriceVolumeOpen InterestLast PriceVolumeOpen Interest
No data available
Unlock Option Chain data
Unlock Options Chart data
Open interest
0 600K 1.2M 1.8M Avg OI 1.00 M Open Interest
0 1 2 3 1.1 Put-Call Ratio
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
0 450K 900K 1.4M Avg OV 750.00 K Option Volume
0 1 2 3 0.95 Put-Call Ratio
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
MDAI
Jul 29, 2026
MDAIConferences/Events
▲ +5.3%on this news

Spectral AI Schedules 2026 Second Quarter Financial Results and Conference Call

Spectral AI, Inc. will report its second quarter financial results on August 11, 2026, followed by a conference call at 5:00 PM ET. The company focuses on AI-driven medical diagnostics for wound care, particularly for burns, and aims to improve treatment decisions. The DeepView System is designed to provide immediate assessments of wound healing potential.

Read more →
MDAI
Jul 8, 2026
MDAIGeneral

Spectral AI Names Darcy Bajko Chief Commercial Officer to Lead Global Sales Launch of FDA-Cleared DeepView® System for Burn Indication

Spectral AI has appointed Darcy Bajko as Chief Commercial Officer to lead the global launch of its FDA-cleared DeepView System for burn indications. This appointment marks a strategic shift for the company as it transitions from product development to commercial execution. Bajko brings extensive experience from leading medical device companies and aims to drive clinical adoption and establish revenue streams.

Read more →
MDAI
Jun 12, 2026
MDAIGeneral

Spectral AI Joins the American Board of Wound Management Foundation in Celebrating Wound Healing Awareness Month

Spectral AI, Inc. is partnering with the American Board of Wound Management Foundation to celebrate the 10th Annual Wound Healing Awareness Month. The company highlights its AI-driven DeepView System, which aids in diagnosing burn wounds and improving treatment outcomes. This initiative underscores the importance of timely care for patients with complex wounds.

Read more →
MDAI
Jun 11, 2026
MDAIConferences/Events

Spectral AI to Participate in 2026 British Burn Association Annual Conference

Spectral AI, Inc. will participate in the 2026 British Burn Association Annual Meeting, showcasing its FDA-approved DeepView System for burn wound assessment. The conference, held at Nottingham Trent University, will feature multiple presentations on the technology. The company anticipates its first commercial sales of the DeepView System by the end of 2026.

Read more →
MDAI
Jun 1, 2026
MDAIGeneral

Spectral AI Announces Voting Results of Annual Meeting of Stockholders

Spectral AI, Inc. announced the results of its 2026 Annual Meeting of Stockholders, where all proposals were approved. The company received FDA clearance for its DeepView System, allowing for commercial distribution in the U.S. Additionally, it secured $31.7 million in funding from BARDA to enhance the system's features. The company is set to initiate commercial sales by the end of 2026.

Read more →
MDAI
May 26, 2026
MDAIFDA Updates
▼ -11.6%on this news· ran to -23% by day 3

Spectral AI Receives FDA De Novo Clearance for DeepView® System for Burn Indication

Spectral AI has received FDA De Novo Classification for its DeepView System, which is designed for assessing burn wound healing potential. This clearance allows the company to begin commercial distribution in the U.S. The DeepView System utilizes AI and multispectral imaging to provide rapid diagnostic assessments, potentially enhancing patient outcomes in burn care.

Read more →
MDAI
May 13, 2026
MDAIGeneral
▼ -5.1%on this news

Real-Time Intoxication Detection Platforms Target Expanding Multibillion-Dollar Healthcare Opportunities

MindBio Therapeutics is developing an AI-driven platform that uses voice analysis to detect intoxication in real-time. This innovative approach aims to address the limitations of traditional drug and alcohol testing methods, which are often invasive and slow. The company targets a substantial market in workplace safety and substance testing, estimated at $47 billion. By focusing on multi-substance detection, MindBio is positioning itself at the forefront of a growing field in noninvasive diagnostics.

Read more →
MDAI
May 12, 2026
MDAIGeneral
▼ -7.7%on this newsshared move

Spectral AI Announces 2026 First Quarter Financial Results

Spectral AI reported its financial results for Q1 2026, highlighting a net loss of $3.4 million. The company continues to develop its DeepView System under a $31.7 million BARDA contract. Despite a decline in R&D revenue, gross margins improved, and the company reaffirmed its annual revenue guidance of approximately $18.5 million.

Read more →
MDAI
Apr 30, 2026
MDAIGeneral
▲ +5.7%on this news· ran to +17% by day 3

Spectral AI Wins Small Business Innovator Award at Inaugural Texas Innovation Conference

Spectral AI, Inc. received the Small Business Innovator Award at the Texas Innovation Conference for its DeepView System, an AI-driven diagnostic tool for assessing burn wound healing potential. The award acknowledges the company's efforts in transforming medical diagnostics and improving patient care. The DeepView System is designed to provide clinicians with immediate, data-driven assessments to enhance treatment decisions.

Read more →
MDAI
Apr 28, 2026
MDAIConferences/Events

Spectral AI Schedules 2026 First Quarter Financial Results and Conference Call

Spectral AI, Inc. will report its first quarter financial results for 2026 on May 12. A conference call will follow at 5:00 PM ET to discuss these results. The company is focused on advancing medical diagnostics in wound care through its DeepView System, which aims to enhance treatment decisions and patient outcomes.

Read more →
MDAI
Apr 22, 2026
MDAIConferences/Events

Spectral AI’s DeepView® System Showcased at 2026 American Burn Association Annual Meeting

Spectral AI showcased its DeepView System at the 2026 American Burn Association Annual Meeting, highlighting its potential in burn wound assessment. The AI-driven device provides immediate, data-driven evaluations to aid treatment decisions. Clinicians from the U.S. and U.K. presented various studies related to the system, emphasizing its innovative approach to improving patient care.

Read more →
MDAI
Apr 20, 2026
MDAIGeneral

Spectral AI Announces Annual Meeting of Stockholders

Spectral AI, Inc. has announced its 2026 Annual Meeting of Stockholders to be held on May 29, 2026. Only stockholders of record as of April 1, 2026, can vote at the meeting. The company is focused on advancing medical diagnostics in wound care with its DeepView System, which aims to improve treatment decisions.

Read more →
MDAI
Apr 9, 2026
MDAIConferences/Events

Spectral AI to Feature DeepView® System at 2026 American Burn Association Annual Meeting

Spectral AI, Inc. will showcase its DeepView® System at the American Burn Association Annual Meeting from April 14-17, 2026. The system offers predictive diagnostics for burn wounds, enabling clinicians to make informed treatment decisions. The company aims to revolutionize wound care management and has submitted a De Novo 510(k) application to the FDA for the system.

Read more →
MDAI
Apr 8, 2026
MDAIGeneral

Spectral AI Names David McGuire, CPA, as Chief Financial Officer

Spectral AI has appointed David McGuire as Chief Financial Officer, effective May 4, 2026. McGuire brings over 20 years of experience in finance and accounting, previously serving as Chief Accounting Officer at Solo Brands. His role is crucial as the company prepares for the commercialization of its DeepView System, aimed at improving wound care diagnostics.

Read more →
MDAI
Mar 25, 2026
MDAIGeneral
▼ -6.7%on this news

Spectral AI Announces 2025 Fourth Quarter and Full Year Financial Results and Introduces Revenue Guidance for 2026 Overview Full Year Research & Development Revenue of $19.7 Million; Q4 2025 Revenue of $3.8 Million Cash

Spectral AI, Inc. (MDAI) reported positive financial results for Q4 and FY 2025, indicating a notable turnaround with a net income of $0.6 million in the fourth quarter. The company received significant funding from BARDA to accelerate the development of its DeepView System, which has gained exceptional reception at recent burn conferences. Despite these positives, the revenue from R&D decreased and the company projects modest revenue growth for 2026. Overall, Spectral AI remains focused on its strategic priorities and commercialization plans for its innovative diagnostic device.

Read more →
MDAI
Mar 18, 2026
MDAIFDA Updates
▼ -6.2%on this news· ran to +34% by day 3

Spectral AI Awarded $31.7 Million of BARDA Funding to Accelerate Development of the DeepView® System

Spectral AI has secured $31.7 million in funding from BARDA to enhance its DeepView System, an AI-driven technology for burn wound imaging. This funding is part of a larger contract aimed at improving medical diagnostics in burn care. The DeepView System is designed to assist healthcare professionals in making quicker, data-driven treatment decisions, particularly in emergency scenarios.

Read more →
MDAI
Mar 10, 2026
MDAIConferences/Events

Spectral AI Schedules 2025 Fourth Quarter and Full Year Financial Results and Conference Call

Spectral AI, Inc. has announced that it will report its financial results for the fourth quarter and full year ended December 31, 2025, on March 24, 2026. The company will host a conference call at 5:00 pm Eastern Time to discuss these results. Their DeepView System aims to provide advanced diagnostics for wound care, particularly for burn patients, with the goal of enhancing treatment decisions and patient outcomes.

Read more →
MDAI
Feb 10, 2026
MDAIGeneral

Spectral AI Names Vincent S. Capone as Chief Executive Officer

Spectral AI has appointed Vincent S. Capone as its new Chief Executive Officer, effective February 9, 2026. Capone, previously the Chief Financial Officer and General Counsel, will lead the company as it transitions towards the commercialization of its AI-driven burn wound assessment device, the DeepView System. His leadership is expected to guide the company's strategic direction and enhance its innovative offerings in wound care.

Read more →
MDAI
Feb 2, 2026
MDAIGeneral

Spectral AI to Participate in National Burn Awareness Week 2026 February 1–7, 2026

Spectral AI, Inc. will participate in National Burn Awareness Week from February 1-7, 2026, collaborating with the American Burn Association to promote burn prevention strategies. The company will engage employees through various activities and highlight the importance of proactive safety measures in workplaces. Additionally, Spectral AI's DeepView System aims to enhance treatment decisions for burn injuries through predictive diagnostics.

Read more →
MDAI
Nov 11, 2025
MDAIGeneral
▼ -7%on this news

Spectral AI Announces 2025 Third Quarter Financial Results

Spectral AI, Inc. reported its Q3 2025 financial results, revealing a cash position of $10.5 million and a decline in research and development revenue by 54% to $3.8 million. The company is progressing towards its De Novo FDA submission and has adjusted its revenue guidance for FY 2025 down to $18.5 million. Despite the challenges, operational efficiency remains a focus.

Read more →
MDAI
Oct 28, 2025
MDAIConferences/Events

Spectral AI Schedules 2025 Third Quarter Financial Results and Conference Call

Spectral AI, Inc. announced its third quarter financial results will be reported on November 11, 2025. The company will host a conference call at 5:00 pm ET to discuss these results. Spectral AI focuses on AI-driven medical diagnostics, particularly in wound care, aiming to improve treatment outcomes with its DeepView System.

Read more →
MDAI
Oct 23, 2025
MDAIGeneral

Spectral AI raises $7.6 Million of Additional Growth Capital

Spectral AI, Inc. has announced a $7.6 million offering to fund the development of its DeepView System, aimed at enhancing medical diagnostics in wound care. The offering involves the issuance of 4 million shares at $1.90 each, with warrants for future purchase. The funding will help the company prepare for commercial readiness by 2026 while continuing its existing projects.

Read more →
MDAI
Sep 19, 2025
MDAIGeneral
▲ +9%on this news

Spectral AI Named to TIME’s List of World’s Top HealthTech Companies 2025

Spectral AI, Inc. has been named to TIME's World’s Top HealthTech Companies 2025 list, highlighting its innovative work in medical diagnostics for wound care. The recognition reflects the company's financial performance, reputation, and online engagement among thousands of HealthTech firms. Chairman J. Michael DiMaio emphasized the significance of this milestone for their DeepView technology, aimed at enhancing treatment decisions.

Read more →
MDAI
Sep 10, 2025
MDAIConferences/Events

DeepView® System highlighted at the European Burns Association Congress

Spectral AI, Inc. showcased its DeepView System at the European Burns Association Congress, highlighting its role in advancing burn care. Presentations from various experts emphasized the technology's effectiveness and the positive reception it received. The company aims to enhance treatment decisions in wound care through its innovative AI-driven solutions.

Read more →
MDAI
Aug 12, 2025
MDAIFDA Updates
▼ -5.5%on this news

Spectral AI Announces 2025 Second Quarter Financial Results Q2 Overview Research & Development Revenue of $5.1 Million, total revenue for the first half of 2025 of $11.8 Millon Strong Cash position of $10.5 Million Submi

Spectral AI, Inc. announced its financial results for Q2 2025, showcasing a significant milestone with the submission of its De Novo application to the FDA for its DeepView System. This innovative diagnostic device aims to enhance clinical decision-making in wound care. The company reported a decrease in R&D revenue but improved its cash position to $10.5 million. Despite a net loss widening to $(7.9) million for the quarter, management remains optimistic about its future and continues to focus on cost efficiencies.

Read more →
MDAI
Jul 30, 2025
MDAIConferences/Events

Spectral AI Schedules 2025 Second Quarter Financial Results and Conference Call

Spectral AI, a developer focused on medical diagnostics, announced that it will report its second-quarter financial results on August 12, 2025. The company will conduct a conference call to discuss these results, which will be accessible via phone and online webcast. Spectral AI's DeepView System aims to enhance wound care management by providing clinicians with immediate assessments of burn wounds. The goal of this technology is to revolutionize treatment decisions and improve patient care efficiency.

Read more →
MDAI
Jun 30, 2025
MDAIFDA Updates
▲ +17%on this news· ran to +27% by day 1

Spectral AI Announces Submission to FDA of its DeepView® System

Spectral AI has submitted a De Novo 510k marketing clearance application to the FDA for its DeepView System, which uses AI and multispectral imaging to assess burn healing potential. This submission marks a crucial step towards bringing the innovative device to market, aimed at enhancing clinical decision-making and patient outcomes in burn care settings.

Read more →
MDAI
Jun 10, 2025
MDAIConferences/Events

DeepView® System highlighted at the annual British Burn Association conference

Spectral AI showcased its DeepView System at the British Burn Association conference, highlighting its potential to improve burn care. Key presentations revealed early positive experiences, including enhanced detection rates of non-healing wounds and improved clinical decision-making. The company's commitment to advancing burn treatment was emphasized by its leadership.

Read more →
MDAI
May 30, 2025
MDAIGeneral

Spectral AI Announces Appointment of Stanley Micek as Chief Operating Officer

Spectral AI has appointed Stanley Micek as Chief Operating Officer, transitioning from his role as Interim COO. Micek's leadership has been pivotal in overseeing teams working on the company's FDA submission and advancing their innovative DeepView® System for wound care. His experience in healthcare positions him well to lead the company's operational strategies.

Read more →
MDAI
May 29, 2025
MDAIGeneral

Spectral AI Announces Voting Results from 2025 Annual Meeting of Stockholders DALLAS, TX

Spectral AI, Inc. announced the voting results from its 2025 Annual Meeting of Stockholders, where significant shareholder participation was recorded with over 60% of total shares represented. Both proposals presented were approved, including the election of six directors to the Board of Directors for another term. Additionally, the appointment of KPMG LLP as the independent registered public accounting firm was ratified, reinforcing the company's commitment to corporate governance and accountability. Spectral AI continues to focus on AI-driven medical diagnostics aimed at improving wound care outcomes.

Read more →
MDAI
May 20, 2025
MDAIGeneral

Spectral AI Research Partner Using DeepView System Wins Best Research Project at the 2025 Education Awards

Spectral AI, Inc. announced that its research partners have received the Best Research Project award at the 2025 Education Awards for their work on diabetic foot ulcers using the DeepView System. This recognition highlights the innovative use of AI-driven imaging to improve treatment evaluations and strategies. The company’s Chief Commercialization Officer noted that the research strengthens the clinical evidence for their technology and supports future commercialization efforts. Overall, the award signifies a significant milestone in validating the effectiveness of the DeepView System in medical diagnostics.

Read more →
MDAI
May 13, 2025
MDAIGeneral

Spectral AI Announces 2025 First Quarter Financial Results Q1 Overview Research & Development Revenue of $6.7 Million Improved Capital Structure Reflected in Cash of $14.1 Million Continued work on planned De Novo submis

Spectral AI, Inc. announced its financial results for Q1 2025, reporting a research and development revenue increase to $6.7 million. The company improved its cash reserves significantly to reach $14.1 million and indicated progress towards its FDA De Novo submission. A Burn Validation Study was completed, demonstrating the DeepView System's effectiveness in predicting burn wound healing. The firm remains focused on advancing its strategic goals and achieving a revenue target of approximately $21.5 million for FY 2025.

Read more →
MDAI
May 2, 2025
MDAIConferences/Events

Spectral AI Schedules 2025 First Quarter Financial Results and Conference Call

Spectral AI, Inc. will announce its financial results for the first quarter of 2025 on May 13, following a market close. The company, known for its AI-powered DeepView® System aimed at improving burn treatment outcomes, is hosting a conference call to discuss these results. This initiative underscores the company's focus on transparency and commitment to advancing medical diagnostics in wound care. As a forward-looking company, it acknowledges the inherent risks and uncertainties involved in its projections.

Read more →
MDAI
Mar 27, 2025
MDAIGeneral

Spectral AI Announces 2024 Fourth Quarter and Full Year Financial Results 2024 Research & Development Revenue of $30 Million Successful Results from the US Burn Validation Study On Track for Regulatory Submission in US f

Spectral AI, Inc. announced its financial results for Q4 and FY 2024, reporting a significant jump in research and development revenue to $30 million. The company noted successful outcomes from its US Burn Validation Study and is progressing toward regulatory submission for its DeepView System aimed at improving wound care. Despite these accomplishments, Spectral AI posted a net loss of $(15.3) million for the year, highlighting ongoing financial challenges as it prepares for commercialization in 2025.

Read more →
MDAI
Mar 24, 2025
MDAIGeneral
▼ -12.4%on this news· ran to -25% by day 3shared move

Spectral AI Raises up to $15 Million of Debt Financing and Strengthens Financial Position for U.S. Commercialization Your publication date and time will appear here. | Source: Spectral AI , Inc. Share DALLAS

Spectral AI has announced the successful raise of up to $15 million in debt financing, aimed at supporting the U.S. commercialization of its DeepView System. This predictive AI technology intends to enhance the assessment of burn wound healing potential, thereby improving treatment decisions for healthcare providers. The partnership with Avenue Capital is expected to yield long-term benefits for Spectral AI, aligning with the goal of revolutionizing wound care management. The clinical data surrounding the DeepView System has garnered positive reviews from financial partners, highlighting its potential impact in the field of medical diagnostics.

Read more →
MDAI
Mar 20, 2025
MDAIGeneral

Spectral AI Announces Public Filing of Registration Statement for Proposed Initial Public Offering of Spectral IP

Spectral AI has announced the public filing of a registration statement for its subsidiary, SIM IP Inc., planned as an initial public offering. This follows the company's pioneering work with its AI-driven DeepView® System, designed for faster burn wound healing assessments. The exact terms of the IPO remain undetermined, and there are uncertainties regarding its approval and listing. Despite the innovative prospects, risks include the possibility of application withdrawal and market conditions affecting the offering.

Read more →
MDAI
Mar 17, 2025
MDAIFDA Updates
▲ +13.5%on this newsshared move

Spectral AI Announces Successful Results from its Burn Validation Study of the DeepView System DeepView System outperforms burn physicians in identifying non-healing tissue Landmark Burn Validation Study, one of the larg

Spectral AI announced the successful results of its Burn Validation Study for the DeepView System, an AI-driven tool designed to predict the healing potential of burn wounds. The study, one of the largest conducted in the U.S. involving 164 participants, demonstrated that the DeepView System significantly outperforms the clinical judgment of burn physicians. The company plans to submit its findings to the FDA by mid-2025 and aims for De Novo clearance to expedite commercialization of the innovative device in the U.S. market.

Read more →
MDAI
Mar 6, 2025
MDAIGeneral

Spectral AI Completes Three Device Installations in Australia

Spectral AI has successfully completed the installation of three DeepView System devices in Australia, which are designed to provide predictive assessments of burn wound healing. The deployment was facilitated through the Australian Special Access Scheme, allowing the devices to be utilized at several major hospitals. The move is part of the company’s strategy to enhance clinical decision-making and patient outcomes in burn care through innovative technology. The installations also serve as real-world trials to gather data for future FDA submissions.

Read more →
MDAI
Feb 28, 2025
MDAIConferences/Events

Spectral AI Schedules 2024 Fourth Quarter and Full Year Financial Results and Conference Call

Spectral AI (NASDAQ: MDAI) announced that it will report its financial results for the fourth quarter and full year ended December 31, 2024, on March 27, 2025. This announcement will be accompanied by a conference call to discuss the results. The company is known for its DeepView System, which utilizes AI-driven technology for predicting burn healing potential and aims to enhance treatment decisions in wound care. Spectral AI continues to pursue advancements in medical diagnostics.

Read more →
MDAI
Feb 18, 2025
MDAIFDA Updates
▼ -7.5%on this news

Spectral AI Strengthens Financial Position Ahead of FDA Submission

Spectral AI (NASDAQ: MDAI) has announced the satisfaction of its final obligations under its debt facility with Yorkville Advisors, thus strengthening its financial position. With additional financing of up to $17.5 million available through a standby equity purchase agreement, the company is now progressing towards its FDA submission for the DeepView® System. This AI-driven system aims to improve wound care management by providing quick assessments of burn wound healing potential, which could significantly benefit patient outcomes.

Read more →
MDAI
Feb 7, 2025
MDAIFDA Updates

Spectral AI Completes Data Analysis for U.S. Burn Pivotal Study

Spectral AI has completed data analysis for its U.S. Burn Pivotal Study, which aims to validate the performance of its AI-driven DeepView® System in predicting burn healing potential. The study, one of the largest of its kind, highlights favorable metrics of the DeepView® System when assessed against physician evaluations. Spectral AI plans to submit a De Novo classification request to the FDA by June 2025, marking a significant step in the approval process for its innovative technology. The company aims to enhance wound care management with this predictive device, promising to improve treatment decisions and patient outcomes.

Read more →
MDAI
Jan 28, 2025
MDAIPhases
▲ +5.7%on this news

Spectral AI Completes Pediatric Enrollment in Emergency Departments for U.S. Burn Pivotal Study

Spectral AI has successfully completed pediatric enrollment for its U.S. Burn Pivotal Study, one of the largest burn studies conducted in the U.S. This study aims to validate the AI-driven DeepView System's effectiveness in predicting burn healing potential. The company plans to pursue a De Novo classification from the FDA, with a submission expected in the first half of 2025. The DeepView System utilizes advanced imaging and algorithms to enhance clinical decision-making in burn treatment.

Read more →
MDAI
Jan 22, 2025
MDAIGeneral

Spectral AI Provides Update to Investors

Spectral AI (NASDAQ: MDAI) provided an update indicating that it expects annual revenue for 2024 to exceed $28 million, marking the highest in its history. This growth is linked to a focus on the BARDA contract and is expected to improve its gross profit margin. The company also anticipates having over $5 million in cash. However, the financial statements are yet to be audited, and the preliminary results may be subject to material adjustments.

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MDAI
Dec 31, 2024
MDAIGeneral
▼ -7.2%on this news

Spectral AI Provides Instructions for Retail Investors on Exercising Publicly-Traded Warrants

Spectral AI has announced detailed instructions for retail investors on how to exercise their publicly-traded warrants. The company, known for its AI-driven DeepView System, emphasizes the steps involved such as contacting brokerage firms and ensuring sufficient funds are available. The DeepView System, designed to predict burn healing potential, has received Breakthrough Device Designation from the FDA. This announcement reflects the company's commitment to improve healthcare solutions in wound care.

Read more →
MDAI
Dec 23, 2024
MDAIGeneral
▲ +11.1%on this news· ran to +46% by day 3

Spectral AI Announces Confirmation of Compliance of its Nasdaq Listing Requirements DALLAS

Spectral AI, a developer of medical diagnostic technology, has announced that it has regained compliance with Nasdaq's listing standards. The confirmation came in a letter dated December 20, 2024, which indicated that a further compliance hearing is unnecessary. The company is optimistic about its future, particularly concerning its upcoming submission to the FDA for its DeepView System, designed to enhance treatment decisions for wounds. Dr. Michael DiMaio, the Chairman of Spectral AI's Board, expressed pride in the team's efforts and commitment to innovation.

Read more →
MDAI
Dec 13, 2024
MDAIGeneral
▼ -10.9%on this news

Spectral AI Comments on Compliance with Nasdaq Listing Rule 5550(b)(2)

Spectral AI has announced that it believes it has regained compliance with Nasdaq Listing Rule 5550(b)(2) after its market value exceeded $35 million for 10 consecutive business days. The company is awaiting confirmation from Nasdaq regarding this compliance. Spectral AI's DeepView® System, which uses AI for predicting burn healing potential, continues to focus on enhancing treatment decisions in wound care, particularly for burns and diabetic foot ulcers.

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MDAI
Dec 12, 2024
MDAIFDA Updates

Spectral AI Highlights Unprecedented Collaboration with National Leaders in Burn Care for DeepView™ System Training and Validation Studies

Spectral AI announced a significant collaboration with national burn care leaders to advance the training and validation studies for its DeepView™ System. This initiative involves over 511 in-person days from renowned experts, aiming to enhance the system's credibility for FDA submission. The DeepView technology, which has already garnered Breakthrough Device Designation from the FDA, focuses on predicting wound healing potential using advanced AI and imaging. The collaborative effort reflects a strong commitment to establishing DeepView as a gold-standard tool in burn care diagnosis and treatment.

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MDAI
Dec 9, 2024
MDAIGeneral

Spectral AI Incorporates Frontline Feedback into Improved Software Release for Enhanced Diagnostic Precision

Spectral AI has announced significant improvements to its software for the DeepView SnapShot® M and AI-Burn® systems, based on clinician feedback, solidifying its commitment to enhancing medical diagnostics in wound care. The updates aim to improve product performance and usability, with plans for implementation in the UK and support for Australian burn centers. This regulatory milestone underscores the company's dedication to integrating real-world insights into its technology, ensuring better patient outcomes.

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MDAI
Dec 2, 2024
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Spectral AI Completes Truthing of Burn Center Images, Initiates Emergency Department Image Review

Spectral AI has completed the truthing phase for images from U.S. burn centers, marking a significant achievement in training its DeepView® System for accurate wound healing predictions. The company is now initiating a similar truthing process for images from emergency departments, expanding its system's functionality across various clinical scenarios. The progress includes collaboration with top specialists, aiming to provide faster and more accurate diagnostics, ultimately supporting an FDA submission for its DeepView AI®-Burn device in early 2025. This advancement positions Spectral AI as a key player in enhancing treatment decisions for burn victims.

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MDAI
Nov 26, 2024
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Spectral AI Announces Repricing of its Public Warrants

Spectral AI has announced a repricing of its publicly-traded common share purchase warrants, reducing the exercise price from $11.50 to $2.75 per share. This change applies to all 8,433,333 outstanding warrants and follows a twenty-day notice period. The company could potentially raise up to $23 million if all warrants are exercised. Spectral AI specializes in using AI technology for advanced medical diagnostics, particularly in wound care management.

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MDAI
Nov 21, 2024
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Spectral AI Announces DeepView SnapShot M Moves Forward with Feedback from Brooke Army Medical Center Institute of Surgical Research

Spectral AI has announced progress in the development of its DeepView SnapShot M device, based on initial feedback from the Brooke Army Medical Center. This device is designed for advanced wound care diagnostics using AI-powered multispectral imaging and aims to serve military and emergency medical sectors. The company is committed to ongoing design improvements and rigorous testing to ensure effectiveness in real-world applications. With more than $7.2 million in government funding, the technology holds potential to significantly impact battlefield triage and healthcare delivery for chronic wounds.

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MDAI
Nov 19, 2024
MDAIFDA Updates
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Spectral AI Raises Up to $5 Million Financing Strengthening Financial Position for FDA Pathway

Spectral AI, Inc. has announced a successful completion of approximately $5 million in equity financing to enhance its financial position. The company plans to utilize part of these funds to retire existing obligations and further its development efforts aimed at FDA approval for its DeepView AI®-Burn system, expected in early 2025. The financing arrangement involved institutional investors, indicating strong support for the company's growth. The proceeds bolster Spectral AI’s balance sheet and operational flexibility for future advancements in AI-driven medical diagnostics.

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MDAI
Nov 6, 2024
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Spectral AI Announces Plan to Spin Off Spectral IP Subsidiary Focused on Intellectual Property Investments and Monetization

Spectral AI, Inc. (MDAI) plans to spin off its subsidiary, Spectral IP, which will focus on intellectual property investments, through a transaction with Sauvegarder Investment Management. This spinoff aims to maximize shareholder value by creating a sharper strategic focus for both the parent and subsidiary companies. Spectral AI's patents and applications will remain with the parent company, while Spectral IP is set to operate independently with a goal of delivering IP financing and monetization solutions across industries, particularly in healthcare. The spinoff is expected to be completed in the next 90 days, pending necessary approvals.

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MDAI
Nov 6, 2024
MDAIFDA Updates

Spectral AI Announces 2024 Third Quarter Financial Results

Spectral AI, Inc. reported its third quarter financial results for 2024, showcasing a significant revenue increase of 138% to $8.2 million. The company reaffirmed its regulatory submission timeline to the U.S. FDA for its DeepView AI-Burn system, with a submission planned for Q2 2025. Additionally, the recent completion of the last patient visit for their pivotal burn study positions the company well for forthcoming top line results expected in December 2024. Spectral AI also intends to spin-off its subsidiary, Spectral IP, Inc., to enhance shareholder value.

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MDAI
Oct 30, 2024
MDAIPhases
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Spectral AI Announces Last Patient Out in U.S. Burn Pivotal Study at Burn Centers

Spectral AI, Inc. has announced the successful completion of clinical visits with the last group of patients in its U.S. Burn Pivotal Study, which is a significant milestone towards FDA submission expected in 2025. The study, involving 160 patients across 14 burn centers, seeks to validate the DeepView® System designed for assessing burn wound healing. Topline results will be reported in December 2024, and the device promises to enhance treatment decision-making and overall patient care in burn management.

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MDAI
Oct 23, 2024
MDAIConferences/Events
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Spectral AI Schedules 2024 Third Quarter Financial Results and Conference Call

Spectral AI, Inc. announced it will release its financial results for the third quarter of 2024 on November 6, 2024, followed by a conference call at 5:00 pm Eastern Time. The company, based in Dallas, specializes in AI solutions for medical diagnostics, particularly in wound care. Their DeepView® System offers clinicians assessment capabilities for wound healing potential, aimed at enhancing patient outcomes and reducing healthcare costs. Investors are invited to join the live call or access the webcast via the company's Investor Relations page.

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MDAI
Oct 14, 2024
MDAIGeneral

Spectral AI, Inc. Announces Return of Founder Dr. J. Michael DiMaio as Chairman of the Board of Directors DALLAS

Spectral AI, Inc. has announced the return of its founder, Dr. J. Michael DiMaio, as the Chairman of the Board of Directors. The decision, lauded by the current Chairman Richard Cotton, reflects confidence in Dr. DiMaio's leadership and depth of experience in the medical field. The company aims to focus on the commercialization of its DeepView System to improve wound care diagnostics. Additionally, an Office of the Chairman has been created to oversee day-to-day operations and strategic collaborations, ensuring a robust path for the company's future growth.

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MDAI
Oct 3, 2024
MDAIGeneral

Spectral AI Completes Proof of Concept for Wound Measurement Technology

Spectral AI, Inc. has announced the successful completion of a proof-of-concept module for its wound measurement technology that calculates the total body surface area of burns. This advanced technology aims to improve the accuracy and speed of burn size measurements, which is critical for effective treatment decisions in acute burn management. Integrated into the company's DeepView System, it offers sub-millimetric accuracy without the need for manual markers. The company believes this innovation could significantly enhance clinician support and change burn care standards.

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MDAI
Sep 24, 2024
MDAIPhases
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Spectral AI Achieves 25% Patient Enrollment at Emergency Departments for U.S. Burn Pivotal Study and Adds Two New Clinical Trial Sites

Spectral AI, Inc. has announced a significant milestone in its U.S. Burn Pivotal Study, achieving 25% patient enrollment at Emergency Departments. The company has also added two new clinical trial sites, bringing the total to 11. The study aims to validate the AI-based DeepView System for assessing burn wounds and is expected to play a crucial role in improving treatment outcomes. Furthermore, the company plans to submit a De Novo classification request to the FDA for the device in 2025, aiming to enhance the management of burn injuries.

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MDAI
Sep 17, 2024
MDAIFDA Updates

Spectral AI Outlines U.S. Regulatory Pathway for DeepView System for Burn Indication

Spectral AI has outlined its regulatory strategy to enter the U.S. market with its DeepView AI-Burn system, a predictive medical device for assessing burn healing. The company intends to submit a De Novo classification request to the FDA in the second quarter of 2025, following fulfillment of patient enrollment for their pivotal study. The DeepView AI-Burn has received Breakthrough Device Designation, highlighting its potential to enhance clinical decision-making in burn treatment. The innovative platform aims to transform wound care management and improve patient outcomes with timely assessments.

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MDAI
Sep 5, 2024
MDAIGeneral

Spectral AI Awarded Additional Funding from Medical Technology Enterprise Consortium to Support Ongoing Development of DeepView SnapShot M

Spectral AI, Inc. has been awarded over $850,000 by the Medical Technology Enterprise Consortium to further develop its DeepView SnapShot M, a handheld predictive device designed for burn wound assessment in battlefield environments. This funding increases the total amount of non-dilutive government support for the device to over $7 million. The DeepView SnapShot M seeks to enhance the triage process by providing rapid and accurate assessments, improving care for military personnel. Spectral AI's technology is grounded in advanced AI capabilities, aiming to revolutionize wound management and treatment in critical situations.

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MDAI
Aug 28, 2024
MDAIConferences/Events

Spectral AI to Participate in Upcoming Investor Conferences

Spectral AI, Inc. announced participation in upcoming investor conferences, including the H.C. Wainwright 26th Annual Global Investment Conference and Lake Street BIG8 Investor Conference. The company is focused on AI-based medical diagnostics to enhance treatment decisions in wound care, specifically targeting burns and diabetic foot ulcers. Their DeepView System is designed to provide immediate assessments of wound healing potential. This engagement seeks to garner interest in their innovative solutions while providing an update on the company's strategic direction.

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MDAI
Aug 27, 2024
MDAIPhases

Spectral AI Completes Burn Center Enrollment for U.S. Burn Pivotal Study

Spectral AI has completed patient enrollment for its U.S. Burn Pivotal Study, one of the largest studies of its kind in the U.S., aimed at validating its DeepView System for assessing burn treatment. The company plans to use data collected from adult and pediatric patients to seek FDA approval for the DeepView System in burn centers in 2025. The quick enrollment of 160 patients highlights the study's efficiency and the commitment of the involved parties. This pivotal study marks a significant advancement in the company's efforts to improve wound care diagnostics and treatments.

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MDAI
Aug 19, 2024
MDAIConferences/Events

Spectral AI Announces Podium Presentation at BBA / ISBI Joint Conference Assessing Burn Wound Severity Using Multispectral Imaging and Artificial Intelligence

Spectral AI, Inc. announced that Dr. Jeffrey Carter will present findings from a multicenter study utilizing the company’s DeepView™ System to assess burn wound severity through multispectral imaging. This technology aims to address the challenges posed by limited resources in burn care, especially during mass casualty events. The DeepView™ System demonstrates superior accuracy over traditional assessments, potentially improving patient outcomes. The ongoing study is part of the company's efforts to validate the AI-driven model prior to seeking FDA approval for burn indication in 2025.

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MDAI
Aug 12, 2024
MDAIGeneral
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Spectral AI Announces 2024 Second Quarter Financial Results

Spectral AI, Inc. reported financial results for the second quarter of 2024, highlighting a revenue of $7.5 million, primarily due to advancements in its DeepView system for wound care. The company has seen patient enrollment surpass 85% for its U.S. Burn Pivotal Study, positioning itself for regulatory submission by early 2025. Anticipated commercial revenues in the U.K. mark a significant milestone as the company continues to develop its AI-driven technology. However, general and administrative expenses increased, highlighting ongoing operational costs amid growth.

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MDAI
Aug 9, 2024
MDAIPhases

Predictive Wound Healing AI + Multispectral Imaging = Faster, More Accurate Treatment Decisions in Healthcare N a s d a q: M D A I | A u g u s t 2 0 2 4 A I - D r i v e n w o u n d assessment technology designed to deliv

MDAI has introduced an AI-driven wound assessment technology that combines predictive wound healing and multispectral imaging to enhance treatment accuracy in healthcare. The DeepView system allows quick assessments during initial patient visits, significantly reducing the time to surgery and unnecessary procedures. Supported by substantial government funding and a strong competitive position, MDAI's technology aims to revolutionize management of burns and diabetic foot ulcers. The company anticipates significant market opportunities from its proprietary platform across multiple clinical indications.

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MDAI
Jul 31, 2024
MDAIConferences/Events

Spectral AI Announces Continuing Progress in Development of Handheld DeepView SnapShot M for Military Field Use

Spectral AI, Inc. has announced continuing advancements in its DeepView SnapShot M, a handheld diagnostic tool designed for burn wound assessment in military settings. The device, part of a larger project aimed at improving battlefield triage, is being optimized to ensure accurate image capture amidst challenging conditions. Spectral AI will also present its findings at the upcoming Military Health System Research Symposium in August 2024, emphasizing its commitment to supporting armed forces and emergency responders. The company is focused on enhancing medical diagnostics through AI technology.

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MDAI
Jul 29, 2024
MDAIConferences/Events
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Spectral AI Schedules 2024 Second Quarter Financial Results and Conference Call

Spectral AI, Inc. plans to announce its financial results for the second quarter of 2024 on August 12, following the close of the stock market. A conference call will be held that evening to discuss the results in depth. The company is known for its DeepView System, which seeks to provide predictive assessments for wound care treatments, aiming to enhance patient outcomes and lower healthcare costs. Investors can participate in the call and access the webcast through the company's investor relations page.

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MDAI
Jul 24, 2024
MDAIGeneral

Spectral AI Announces Total U.S. and International Patent Portfolio Now Stands at 26 Granted Patents and 38 Pending Applications in Support of its AI-Driven DeepView System

Spectral AI, Inc. announced a significant expansion in its patent portfolio, which now includes 26 granted patents and 38 pending applications related to its AI-driven DeepView System for wound assessment. This increase, a 30% rise from the previous total, underscores the company's commitment to innovation in medical diagnostics. The DeepView System aims to enhance wound care management with objective assessments to improve treatment outcomes for patients. The company's leadership emphasizes the importance of protecting its intellectual property as they prepare for product commercialization initiatives set to start in late 2024.

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MDAI
Jul 23, 2024
MDAIPhases

Spectral AI Adds Three New Clinical Trial Sites To Expedite Emergency Department Patient Enrollment

Spectral AI has expanded its 2024 Burn Pivotal Study by adding three new U.S. clinical trial sites, bringing the total to 16. The study aims to validate the DeepView™ System's AI-driven algorithm for burn indication ahead of its anticipated FDA approval in 2025. The additional sites will help facilitate quicker patient enrollment, enhancing the potential impact of the technology on burn patient care. The company's novel approach proposes to streamline the triage process in busy emergency departments, possibly transforming burn treatment standards.

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MDAI
Jul 15, 2024
MDAIGeneral

Spectral AI Continues Support of Naked Short Selling Inquiry DALLAS, TX

Spectral AI, Inc. has announced its continued support for an inquiry into potential naked short selling affecting its stock. The company, under Board member Erich Spangenberg, is collaborating with Nasdaq and state authorities to investigate these allegations. This follows up on prior communications, aiming to address what the company believes could be violations of trading regulations. Additionally, Spectral AI's DeepView System, aimed at enhancing wound care diagnostics, continues to be central to its operations.

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MDAI
Jul 8, 2024
MDAIGeneral

Spectral AI Announces Collaboration with Global Wound Care Company PolyNovo to Introduce DeepView System for Burn Indication to Australian Market

Spectral AI has announced a collaboration with PolyNovo to introduce its DeepView System for burn indications in Australia. This partnership, formalized through a Memorandum of Understanding, involves support from PolyNovo to assist Spectral AI in applying for the Australian Special Access Scheme. The initiative aims to deploy DeepView Systems at two hospitals for evaluation, potentially leading to a broader commercial rollout. The DeepView System promises to enhance clinical assessments of burn wounds, offering an objective evaluation of healing potential using advanced imaging technology.

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MDAI
Jul 3, 2024
MDAIPhases

Spectral AI Expands Clinical Trial Sites for Pivotal U.S. Burn Study

Spectral AI, Inc. has expanded its clinical trial sites for its 2024 Burn Pivotal Study by adding the University of California San Diego and the University of Utah. This addition brings the total number of clinical trial sites in the U.S. to 14, enabling the company to recruit a more diverse patient population. The study aims to validate the company's AI-driven DeepView™ System and is expected to conclude by the end of 2024, following which the company plans to seek FDA approval in 2025.

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MDAI
Jul 2, 2024
MDAIPhases
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Spectral AI Achieves 100% Pediatric Enrollment in Burn Centers for Pivotal U.S. Burn Study

Spectral AI, Inc. has successfully achieved full pediatric enrollment for its pivotal burn study at burn centers, marking a significant milestone for its AI-driven DeepView System. This study aims to validate the use of advanced imaging technology for accurate burn assessments, particularly benefiting children. The company's CEO emphasized the critical importance of timely and accurate evaluations in improving patient outcomes. The study is expected to conclude in the fourth quarter of 2024, paving the way for potential FDA approval in 2025.

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MDAI
Jul 1, 2024
MDAIGeneral
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Spectral AI Joins Russell Microcap Index

Spectral AI, Inc. has been included in the Russell Microcap Index, effective July 1, 2024, which will enhance its visibility among investors. The company continues to advance its AI-driven DeepView System for wound care, with ongoing clinical trials showing promising enrollment progress. Spectral AI also recently received UKCA Authorization for its product in the UK and expects to generate initial revenue soon. Overall, the company is well-positioned for potential growth in the medical diagnostics sector.

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MDAI
Jun 27, 2024
MDAIPhases
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Spectral AI Surpasses 90% of Pediatric Enrollment Target in Burn Centers for Pivotal U.S. Burn Study

Spectral AI, Inc. has announced that it has exceeded 90% of its pediatric enrollment target in burn centers for its pivotal study with the DeepView™ System. This milestone is significant for the company's aim to validate its AI-driven algorithm used in assessing burn injuries. The pivotal study, which also includes adult patients, is anticipated to conclude in Q4 2024 and precedes an expected FDA approval in 2025. The technology promises timely and accurate assessments, essential for effective treatment protocols in pediatric burn cases.

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MDAI
Jun 24, 2024
MDAIGeneral
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Spectral AI Supports Naked Short Selling Inquiry

Spectral AI, Inc. has announced its support for an inquiry by Nasdaq and state securities authorities regarding potential market manipulation through naked short selling of its stock. This inquiry is led by a board member and major shareholder, Erich Spangenberg, who claims that the company's public float has been artificially increased by over 40% due to this practice. The company is focused on revolutionizing wound care with its predictive DeepView System, which aims to enhance treatment decisions and patient outcomes.

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MDAI
Jun 24, 2024
MDAIGeneral
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Spectral AI Supports Naked Short Selling Inquiry DALLAS, TX

Spectral AI, Inc. has announced its support for an inquiry into potential naked short selling of its common stock, collaborating with Nasdaq and state securities authorities. This investigation, led by Board member Erich Spangenberg, aims to address alleged market manipulation that may have artificially inflated the company's public float by over 40%. Spectral AI emphasizes the importance of market integrity and investor protection while leveraging their innovative DeepView System in wound care diagnostics.

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MDAI
Jun 17, 2024
MDAIConferences/Events
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Spectral AI to Participate in the Northland Capital Markets Virtual Growth Conference

Spectral AI, Inc. (Nasdaq: MDAI) will participate in the Northland Capital Markets Virtual Growth Conference on June 25, 2024. The company's CEO and CFO will hold one-on-one meetings with institutional investors. Spectral AI's DeepView™ System, which has received UKCA authorization for burn treatment, is poised to deliver its first commercial revenues later this year. The company is also planning additional regulatory submissions to expand its operations in 2024 and 2025.

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MDAI
Jun 6, 2024
MDAIPhases

Spectral AI Reaches 50% Enrollment at Burn Centers for U.S. Pivotal Burn Study

Spectral AI has announced that it has reached 50% enrollment in its pivotal study at burn centers across the U.S. This study aims to validate the effectiveness of the DeepView™ System for assessing burn injuries and to compare its algorithm against clinician assessment. With a target enrollment of 240 patients, this pivotal study is crucial for seeking FDA approval in 2025. The DeepView™ System utilizes advanced imaging technology to enhance the accuracy of burn wound assessments, promising to improve patient outcomes significantly.

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MDAI
May 29, 2024
MDAIGeneral

Spectral AI Set to Join Russell Microcap Index

Spectral AI, Inc. has announced its inclusion in the Russell Microcap Index, effective June 28, 2024, highlighting its growth as a public company. This milestone follows the company's advancements in medical diagnostics, particularly with its AI-driven DeepView System aimed at improving wound care. The firm anticipates commercializing its products soon, having already gained UKCA authorization and secured a government contract valued at up to $150 million. Overall, this recognition is expected to enhance Spectral AI's profile among investors during a pivotal period in its development.

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MDAI
May 28, 2024
MDAIConferences/Events

Spectral AI to Participate in Benzinga’s “AI Unleashed: Exploring the Possibilities” Virtual Event

Spectral AI, Inc. (Nasdaq: MDAI) announced its participation in Benzinga's 'AI Unleashed: Exploring the Possibilities' virtual event on May 30, 2024. CEO Peter M. Carlson will engage in a fireside chat, discussing the company's innovative approaches in medical diagnostics, specifically for wound care. Spectral AI's DeepView System is designed to provide faster, objective assessments of wound healing potential, potentially improving patient outcomes and reducing healthcare costs. The event is accessible live, and a webcast will also be available for interested parties.

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MDAI
May 17, 2024
MDAIGeneral
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Spectral AI Announces Purchases of Over 100,000 Shares by Insiders

Spectral AI, Inc. announced that several officers and directors purchased approximately 113,000 shares of the company's stock, reflecting confidence in its prospects. The company has made significant progress in commercializing its DeepView System, an AI-driven medical device for wound care, and expects to generate its first product revenue in the second half of 2024 after receiving UKCA Authorization. Furthermore, Spectral AI was awarded a multi-year contract from the US Government for further development of the DeepView System, which is poised to change the standard of care in wound management.

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MDAI
May 15, 2024
MDAIGeneral

Spectral AI Announces Voting Results from 2024 Annual Meeting of Stockholders and the Appointment of Erich Spangenberg to the Board of Directors

Spectral AI, Inc. held its 2024 Annual Meeting of Stockholders on May 14, 2024, where all proposed items were unanimously approved by stockholders. Notably, Erich Spangenberg was appointed to the Board of Directors, expanding the board from six to seven members. The meeting also ratified the 2023 Long Term Incentive Plan and appointed KPMG LLP as the company's independent public accounting firm. The DeepView® system of Spectral AI promises to enhance treatment decisions in wound care through its innovative predictive technology.

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MDAI
May 7, 2024
MDAIGeneral

Spectral AI Announces 2024 First Quarter Financial Results

Spectral AI, Inc. reported its Q1 2024 financial results, revealing a 24.6% increase in research and development revenue to $6.3 million. The company is on track for potential commercial revenue from its DeepView AI-Burn devices deployed in the UK in the second half of 2024. Significant regulatory submissions in the US and UK are planned for 2024 and 2025, reflecting ongoing advancements in their medical diagnostic technologies focused on burn care and diabetic foot ulcers. The company also highlighted improvements in its capital structure, bolstered by a cash reserve increase to $10.2 million.

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MDAI
May 2, 2024
MDAIConferences/Events

Spectral AI to Participate at the Sidoti Micro-Cap Virtual Investor Conference

Spectral AI, Inc. is scheduled to present at the Sidoti Micro-Cap Virtual Investor Conference on May 9, 2024. The presentation will highlight the company's AI-driven DeepView™ System, which aims to improve wound management and patient care. Participants interested in the company's insights into its technology and strategies can register for live and one-on-one meetings. The conference offers an opportunity for investors to engage with the company's management directly.

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MDAI
Apr 30, 2024
MDAIGeneral

Spectral AI Awarded Quality Achievement Award from the Texas Manufacturer Assistance Center

Spectral AI, Inc., recognized for its commitment to quality, has been awarded the Commitment to Quality Achievement Award by the Texas Manufacturer Assistance Center (TMAC). This accolade highlights Spectral AI's innovative approach in medical diagnostics, particularly with its DeepView™ technology that seeks to improve treatment decisions for wound care. The company's advancements aim to enhance patient outcomes while reducing healthcare costs, marking a significant step toward product commercialization. General Manager Louis Percoco expressed pride in the recognition and commitment to quality.

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MDAI
Apr 24, 2024
MDAIConferences/Events

Spectral AI Schedules 2024 First Quarter Financial Results and Conference Call

Spectral AI, Inc. has announced it will report its financial results for the first quarter of 2024 on May 7, 2024. The company, which specializes in AI-driven medical diagnostics, is set to host a conference call at 5:00 pm Eastern Time to discuss these results with investors. Spectral AI is known for its DeepView® System aimed at enhancing wound care treatment decisions, particularly for patients with burns and diabetic foot ulcers. The company emphasizes the ability of its technology to provide immediate and objective assessments of wound healing potential, which could transform current care standards.

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MDAI
Apr 24, 2024
MDAIGeneral

Spectral AI Names Erich Spangenberg CEO of its IP Focused Subsidiary and Explores Potential Spin-Off of that Subsidiary

Spectral AI, Inc. has appointed Erich Spangenberg as the CEO of its health care IP-focused subsidiary, Spectral IP. The company aims to explore a potential spin-off of this subsidiary, seeking to enhance value for shareholders while minimizing management resource requirements. With Spangenberg's background in IP investment, the company believes there are substantial opportunities to deliver value through licensing and acquisitions. A special committee will oversee the implementation of these strategic initiatives.

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MDAI
Apr 1, 2024
MDAIGeneral
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Spectral AI Appoints Jeremiah Sparks as Chief Commercialization Officer

Spectral AI, Inc. has appointed Jeremiah Sparks as Chief Commercialization Officer to lead the company's efforts in bringing its predictive technology, DeepView, to market. Sparks brings over 20 years of experience in medical device marketing and has a strong track record in commercialization strategies. He will focus on both domestic and international markets, aiming to enhance wound care management through AI-driven insights. The company's innovative approach holds promise for improving treatment decisions, particularly for burn patients and diabetic ulcers.

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MDAI
Mar 27, 2024
MDAIGeneral

Spectral AI Announces 2023 Fourth Quarter and Full Year Financial Results 2023 Research & Development Revenue of $18.1 Million Expected to Increase to $28.0 Million in 2024 Commercialization Underway with Revenue Expecte

Spectral AI, Inc. announced its financial results for the fourth quarter and full year of 2023, reporting a research and development revenue of $18.1 million, with expectations to rise to $28.0 million in 2024. The company is moving forward with the commercialization of its DeepView AI system, aimed at improving wound care assessments for burns and diabetic foot ulcers. Despite recent financial losses, management remains optimistic about achieving first revenue from product sales in the second half of 2024 and plans additional regulatory submissions in the US and UK. The company emphasized a solid financial foundation supported by government contracts for future growth.

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MDAI
Mar 20, 2024
MDAIGeneral
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Spectral AI Secures Access to $12.5 Million of New Equity Capital

Spectral AI, Inc. has announced securing $12.5 million in equity capital through a prepaid advance and standby equity purchase agreement, supporting its strategic goals and commercialization plans. This funding comes as the company progresses with its innovative DeepView system aimed at improving wound care management. The equity financing follows the company's recent deployment of a burn care device in the U.K. and ongoing clinical trials in the U.S. market for diabetic foot ulcers.

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MDAI
Mar 20, 2024
MDAIGeneral
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STANDBY EQUITY PURCHASE AGREEMENT THIS STANDBY EQUITY PURCHASE AGREEMENT (this " Agreement ") dated as of

Spectral AI, Inc. has entered into a Standby Equity Purchase Agreement with YA II PN, LTD. The agreement allows the company to issue and sell up to $30 million in newly issued Class A common stock. The funds will be advanced in three tranches contingent upon specific conditions being met. This financial agreement may help boost the company's operations but introduces regulatory and approval challenges.

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MDAI
Mar 19, 2024
MDAIGeneral
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Spectral AI Announces Receipt of $1 Million of Financing for Spectral IP, Inc., its Intellectual Property Subsidiary Focused on the Broader Artificial Intelligence Ecosystem

Spectral AI, Inc. has announced a $1 million investment from an affiliate of its largest shareholder for its newly formed subsidiary, Spectral IP, Inc. This investment aims to enhance the company's positioning within the artificial intelligence ecosystem and focuses on advancing intellectual property through strategic collaborations. The initiative is viewed as a critical step in potentially unlocking additional value for shareholders while maintaining separate capital for the company's core operations. Spectral AI continues to emphasize its commitment to improving medical diagnostics and patient outcomes through innovative AI solutions.

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MDAI
Mar 13, 2024
MDAIConferences/Events
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Spectral AI Schedules 2023 Fourth Quarter and Full Year Financial Results and Conference Call

Spectral AI, Inc. will report its financial results for the fourth quarter and full year ended December 31, 2023, on March 27, 2024. A conference call is scheduled to discuss the results, allowing investors to engage directly. The company is focused on applying AI in medical diagnostics to improve wound care, particularly for burns and diabetic foot ulcers, through its DeepView® system, which provides objective assessments of healing potential.

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MDAI
Mar 12, 2024
MDAIGeneral
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Spectral AI Announces New US Government Contract to Further Accelerate the Development of the Handheld Version of DeepView™ Wound Imaging System

Spectral AI, Inc. has announced a significant contract with the US Government, valued at over $500,000, to further develop the handheld version of its DeepView™ Wound Imaging System. This funding is part of a larger initiative, bringing total funding for the DeepView SnapShot® M to over $6 million. The contract aims to optimize the device's functionality and combat readiness, enhancing its potential for home health care. With a strong emphasis on miniaturization and innovation, the partnership signifies a vital step towards improved medical diagnostics and treatment solutions in wound care.

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MDAI
Mar 7, 2024
MDAIGeneral

Spectral AI Announces Intellectual Property Subsidiary to Focus on the Broader AI Healthcare Ecosystem

Spectral AI, Inc. has established a wholly-owned subsidiary focused on advancing intellectual property within the AI healthcare ecosystem. This initiative aims to enhance the company's IP portfolio and create value for shareholders, especially in the realm of medical diagnostics. CEO Pete Carlson emphasized the collaboration with a recognized expert in IP monetization to guide these efforts. Moreover, the company is positioned to leverage its existing product offerings, including the DeepView system, to improve wound care management.

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MDAI
Feb 29, 2024
MDAIGeneral

Spectral AI Appoints Peter M. Carlson as CEO

Spectral AI has announced the appointment of Peter M. Carlson as CEO, succeeding Wensheng Fan who transitions to Chief Innovation Strategist. The new leadership aims to drive the company's commercialization of its AI-powered DeepView device for predictive wound care. The company has reaffirmed its revenue guidance for 2024, reporting preliminary R&D revenue of approximately $18 million for 2023. Recent milestones include obtaining UKCA authorization and FDA marketing authorization preparation, aiming for initial commercial revenue by late 2024.

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MDAI
Feb 29, 2024
MDAIGeneral

Spectral AI Appoints Peter M. Carlson as CEO Appointment Paves the Way for Company's Next Chapter in Commercialization Phase of AI-Powered DeepView Device for Predictive Wound Care Carlson Brings Proven Track Record of O

Spectral AI has appointed Peter M. Carlson as its new Chief Executive Officer, succeeding Wensheng Fan, who transitions to Chief Innovation Strategist. Carlson, who previously served as CFO, is expected to lead the company's commercialization of its AI-powered DeepView device for predictive wound care. In addition, Spectral AI announced a preliminary R&D revenue of approximately $18 million for 2023 and reaffirmed its revenue guidance of around $28 million for 2024, highlighting the company's growth trajectory and confidence in future initiatives.

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MDAI
Feb 22, 2024
MDAIFDA Updates

Spectral Receives UKCA Authorization for Burn Indication Expected Commercialization 2 nd Half 2024 DALLAS

Spectral AI, Inc. has announced the receipt of UKCA authorization for its DeepView AI-Burn software, which is designed for the diagnosis of burn wounds. The company anticipates deploying six units in the UK and expects to begin generating revenue in the second half of 2024. The DeepView system improves the accuracy of burn assessments, potentially changing the management of burn wounds by reducing the reliance on traditional observation methods. Additionally, the regulatory approval opens up opportunities for expansion into regions such as the Middle East.

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MDAI
Feb 12, 2024
MDAIGeneral

Spectral AI Appoints Dr. J. Michael DiMaio to Board of Directors The Company's two largest stockholders holding approximately 45% of the Company's outstanding shares have extended their lock-up agreements for an addition

Spectral AI, Inc. announced the appointment of Dr. J. Michael DiMaio to its Board of Directors, effective February 7, 2024. Dr. DiMaio, a founder of the company and former CEO, brings substantial expertise in cardiac and thoracic surgery. Additionally, the company's two largest stockholders, who hold approximately 45% of shares, have extended their lock-up agreements for an additional 180 days. The company aims to advance its AI-driven wound care solutions through Dr. DiMaio's leadership.

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MDAI
Feb 6, 2024
MDAIConferences/Events
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Spectral AI to Participate in the 2024 BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference

Spectral AI, Inc. will participate in the BTIG Snowbird MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 13-14, 2024. The company's focus is on leveraging its AI technology, particularly with the DeepView® System, to revolutionize medical diagnostics in wound care. This system is designed to provide quicker and more precise assessment of wound healing, particularly beneficial for patients with burns and diabetic foot ulcers. As a forward-looking statement, the company recognizes the inherent risks and uncertainties that could affect its strategic goals.

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MDAI
Feb 5, 2024
MDAIGeneral

Spectral AI Announces Publication of Letter to Shareholders

Spectral AI has announced a Letter to Shareholders detailing its progress toward commercialization of its AI-driven DeepView System for medical diagnostics in wound care. The highlights include a significant $149 million contract with BARDA, expectations for revenue generation across multiple platforms by 2024, and FDA submissions for its imaging technology. Interim results from clinical studies indicate promising developments in wound care treatment, along with enhancements in the management team. The efforts aim to revolutionize the standard of care in treating burns and diabetic foot ulcers.

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MDAI
Feb 1, 2024
MDAIGeneral

Predictive Wound Healing AI + Multispectral Imaging = Faster, More Accurate Treatment Decisions in Healthcare Nasdaq: MDAI | February 2024 AI - Driven wound assessment technology designed to deliver value across the heal

MDAI has introduced the DeepView system, an AI-driven wound assessment technology designed to enhance treatment decision-making in healthcare. This platform utilizes multispectral imaging to provide rapid and accurate predictions regarding wound healing for conditions such as diabetic foot ulcers (DFU) and burns. With a strong financial backing from government contracts and a unique intellectual property portfolio, the company is well-positioned for growth. Recently, DeepView achieved several critical milestones, including FDA/UKCA classifications and a BARDA Project BioShield contract.

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MDAI
Jan 29, 2024
MDAIFDA Updates

Spectral Submits Application for UKCA Mark Classification

Spectral MD, Inc. has submitted an application in the UK for its DeepView AI®-Burn software to obtain UKCA classification for burn wound use. This marks a significant milestone towards commercialization for this innovative diagnostic tool, which integrates AI to deliver rapid assessments of burn severity. Currently, there are no diagnostic tools available for assessing burn wounds, making this development vital for improving patient care. The company also intends to extend its technology to pediatric patient care.

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MDAI
Jan 11, 2024
MDAIPhases

Spectral AI Begins Enrollment in Pivotal Study to Validate DeepView AI for Burn Injuries

Spectral AI, Inc. has commenced enrollment in a pivotal study to validate its DeepView AI technology for assessing burn injuries. The trial aims to demonstrate the effectiveness of DeepView in predicting wound healing potential from day one, with results intended for FDA submission by mid-2025. The study will take place across various burn centers and emergency departments in the U.S., enrolling both adult and pediatric patients. This effort is backed by substantial government funding and aims to enhance treatment decision-making for burn injuries.

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MDAI
Dec 19, 2023
MDAIGeneral
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Spectral AI Names Industry Veteran and Former Top MiMedx Financial Executive Peter M. Carlson as CFO

Spectral AI has appointed Peter M. Carlson as its new Chief Financial Officer. Carlson, a seasoned financial executive, previously held leadership roles at MiMedx Group and Brighthouse Financial, where he successfully navigated complex financial landscapes. His expertise will be pivotal as Spectral AI aims to market its groundbreaking diagnostic technologies for wound care, which are expected to enhance patient outcomes significantly. Carlson's appointment is seen as a strategic move to bolster the company's growth potential in the healthcare sector.

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MDAI
Nov 30, 2023
MDAIConferences/Events

Spectral AI to Participate in Benchmark’s 12th Annual Discovery One-on-One Conference

Spectral AI, Inc. will participate in the Benchmark 12th Annual Discovery One-on-One Conference in New York City on December 7, 2023. The company focuses on AI-driven medical diagnostics for clinical wound care, particularly for burns and diabetic foot ulcers. Spectral AI recently secured its largest contract from the U.S. Government, worth up to $149 million, to support clinical validation and FDA clearance for its DeepView® System. The company anticipates submitting various applications for FDA and CE mark approvals in the coming years, enhancing its position in the healthcare sector.

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MDAI
Nov 27, 2023
MDAIGeneral

Spectral AI Appoints Erich Spangenberg as Chairman of the Executive Committee of the Board of Directors DALLAS

Spectral AI has appointed Erich Spangenberg as Chairman of the Executive Committee of its Board of Directors. Spangenberg, who has nearly 40 years of experience and is the company's largest shareholder, aims to maximize shareholder value through strategic initiatives. He previously served on the board from 2012 to 2022 and is recognized for his expertise in investment and patent monetization. This leadership change is anticipated to positively impact the company's mission to improve care through AI-driven diagnostics.

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MDAI
Nov 13, 2023
MDAIGeneral

Spectral AI Announces 2023 Third Quarter Financial Results Highlights Continuing Progress in Developing and Commercializing AI-Driven DeepView System Wound Healing Assessment Technology Affirms Full Year Revenue Guidance

Spectral AI, Inc. announced its third quarter financial results for 2023, showcasing significant progress in the development and commercialization of its AI-Driven DeepView System for assessing wound healing. The company secured a record $149 million contract from the U.S. government and anticipates a revenue growth of approximately 60% in 2024. However, Spectral AI reported a net loss of $10.6 million for the quarter, alongside increased operating costs. The upcoming regulatory approvals slated for 2024 and 2025 are pivotal for the commercialization of DeepView technologies.

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MDAI
Nov 1, 2023
MDAIConferences/Events
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Spectral AI Schedules 2023 Third Quarter Financial Results and Conference Call

Spectral AI, Inc. has announced that it will report its third quarter financial results for 2023 on November 13, following which it will hold a conference call on November 14. The company specializes in artificial intelligence for medical diagnostics to improve wound care treatment decisions, particularly for burns and diabetic foot ulcers. Spectral AI aims to significantly enhance current treatment standards with its DeepView® System, which offers objective assessments of wound healing potential.

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MDAI
Oct 24, 2023
MDAIGeneral
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Spectral AI names Prof. Paul Chadwick, Former CEO of the Royal College of Podiatry UK, as Senior Executive for UK and EMEA

Spectral AI, Inc. has appointed Prof. Paul Chadwick as Executive Vice President for its UK subsidiary, leveraging his experience in wound care management. Prof. Chadwick has a strong background in diabetic wound management and is expected to drive market expansion for the company's DeepView® technology in the UK, Europe, Middle East, and Africa. The appointment comes as the company seeks to innovate and improve patient outcomes in wound care with its AI-driven imaging solutions.

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MDAI
Oct 23, 2023
MDAIGeneral
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Spectral AI Provides 2023-2024 Annual Revenue Guidance

Spectral AI, Inc. has provided annual revenue guidance for FY2023 and FY2024, estimating revenues of approximately $17.4 million and $28 million, respectively. The company recently secured its largest contract ever, worth over $149 million from the U.S. Government, significantly boosting future revenue visibility. Spectral AI aims to advance its AI-driven DeepView® Wound Imaging Technology, targeting diabetic foot ulcers and burn care, with plans for regulatory submissions in FY2024. The company is focused on improving wound management outcomes for patients and health systems.

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MDAI
Oct 19, 2023
MDAIFDA Updates
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Spectral AI’s DeepView SnapShot Wound Imaging System, Achieves UKCA Mark and FDA Class 1 Medical Device Classification

Spectral AI, Inc. has announced that its DeepView SnapShot Wound Imaging System has received UKCA marking and FDA Class 1 medical device classification. These regulatory approvals mark important milestones for the company as it focuses on revolutionizing wound care management using artificial intelligence technology. The DeepView SnapShot system is designed to provide accurate assessments of tissue health, supporting healthcare professionals in making informed treatment decisions. The company plans to seek further regulatory approval for its related software to advance its commercial efforts.

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MDAI
Oct 16, 2023
MDAIPhases

Spectral AI Adds Additional Clinical Sites to Multi-Center Diabetic Foot Ulcer (DFU) Study

Spectral AI, Inc. has announced the addition of seven clinical sites to its diabetic foot ulcer (DFU) study which employs the DeepView® Wound Imaging System. This proprietary technology utilizes AI and multi-spectral imaging to provide immediate assessments of wound healing. The data gathered from these new sites will contribute to the development of the DFU healing prediction algorithm and support regulatory applications in the U.S. and Europe. The company's initiative aims to improve patient care and recovery times for DFUs by facilitating quicker access to advanced therapies.

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MDAI
Oct 5, 2023
MDAIConferences/Events

Spectral AI CEO, Wensheng Fan, to Participate in AI Healthcare Panel at Accelerate Health Conference

Wensheng Fan, CEO of Spectral AI, Inc., is set to participate in the Accelerate Health Conference on October 11, 2023. The conference will focus on the role of technology, particularly AI, in improving healthcare practices and patient outcomes. Fan will join other industry leaders in a panel discussion titled 'AI's Medical Odyssey,' which aims to delve into the transformative potential of AI in healthcare. The event is expected to attract around 200 executives, presenting significant networking opportunities.

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MDAI
Oct 2, 2023
MDAIGeneral

Spectral AI Adds Healthcare Services Leader and Population Health Expert Deepak Sadagopan to Board of Directors

Spectral AI, Inc. has appointed Deepak Sadagopan to its board of directors. With over 25 years of experience in healthcare technology and analytics, Sadagopan is expected to contribute significantly to the company's late-stage development of the DeepView System. The system aims to enhance wound care management by providing faster and more accurate treatment decisions. His background in population health and technology aligns with Spectral AI's mission to improve patient outcomes and reduce healthcare costs.

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MDAI
Sep 28, 2023
MDAIGeneral
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Spectral MD Awarded BARDA Project BioShield Contract Valued at $149 Million for AI-Driven DeepView Burn Wound Imaging Technology DALLAS, Sept. 28, 20 23 - Spectral MD, Inc. ("SMD"), a subsidiary of Spectral AI, Inc. (Nas

Spectral MD has been awarded a contract by BARDA valued at up to $149 million for the development of the DeepView burn wound imaging technology. This contract includes an initial award of nearly $55 million focused on clinical validation and FDA clearance, ensuring the technology can support high-demand scenarios such as burn mass casualty incidents. DeepView's AI-driven capabilities promise to improve diagnostic accuracy significantly compared to the current methods. This contract marks the largest funding award in the company's history, enabling further research and development of critical burn care solutions.

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MDAI
Sep 20, 2023
MDAIConferences/Events

Spectral AI to Present at 2023 Cantor Fitzgerald Global Healthcare Conference

Spectral AI, Inc. (Nasdaq: MDAI) will present at the 2023 Cantor Fitzgerald Global Healthcare Conference from September 26-28, 2023. The company's DeepView® System utilizes proprietary technology and AI to assess wound healing potential rapidly. Spectral AI has secured over $130 million in non-dilutive U.S. Government contracts, indicating robust support for its healthcare innovations. This presentation will provide insights into Spectral AI's advancements in medical diagnostics and future clinical applications.

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MDAI
Sep 15, 2023
MDAIGeneral
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SPECTRAL'S MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Unless otherwise indicated or the context otherwise requires, references in this section to "we," "our," "us" or other simi

Spectral AI, previously Legacy Spectral MD Holdings, Ltd., has completed its business combination with Rosecliff Acquisition Corp I, now trading on NASDAQ under the ticker MDAI. The company focuses on AI-driven predictive diagnostics with its DeepView System, which has shown high accuracy in burn wound assessments. Despite receiving substantial government funding and expanding its research into diabetic foot ulcers, Spectral AI has not yet generated product revenue. Regulatory approval for their technology remains uncertain, highlighting risks associated with future financial performance.

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MDAI
Aug 14, 2023
MDAIGeneral

Spectral MD Holdings, Ltd. (“Spectral MD” or the “Company”) ISO 13485 Certification Received for AI-Driven DeepView Wound Imaging System

Spectral MD Holdings, Ltd. has announced it received ISO 13485 certification for its AI-driven DeepView Wound Imaging System, which specializes in treating burn and Diabetic Foot Ulcer (DFU) indications. This certification is a recognition of the company's commitment to quality management systems in the manufacturing and distribution of medical devices. The DeepView platform integrates advanced technology to provide immediate assessments of wound healing, aiming to facilitate treatment decisions and improve overall patient care. Additionally, the company is advancing its regulatory submissions and preparing for commercialization of its product.

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MDAI
Jun 22, 2023
MDAIFDA Updates

An artificial intelligence company focusing on medical diagnostics to deliver faster and more accurate treatment decisions Wensheng Fan Co - Founder and Chief Executive Officer Vincent Capone General Counsel and Corporat

Spectral MD, an artificial intelligence company, is advancing its DeepView System, which has received FDA Breakthrough Device Status for burn wounds and is set to expand into diabetic foot ulcers. The company has secured over $130 million in U.S. government contracts to support its initiatives. With a strong competitive edge via its extensive patent portfolio and a clinically validated data set, the DeepView System aims to significantly improve treatment decision-making in critical wound care scenarios. The market potential for both burn care and diabetic foot ulcer treatments is estimated to be over $14.7 billion by 2028.

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MDAI
Mar 24, 2022
MDAIGeneral

INDEX TO FINANCIAL STATEMENT Page Audited Financial Statement of Rosecliff Acquisition Corp I: Report of Independent Registered Public Accounting Firm F-2 Balance Sheet as of

INDEX TO FINANCIAL STATEMENT Page Audited Financial Statement of Rosecliff Acquisition Corp I: Report of Independent Registered Public Accounting Firm F-2 Balance Sheet as of February 17, 2021 (as restated) F-3 Notes to Financial Statement (as restated) F-4 REPORT OF IND

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MDAI
Mar 11, 2022
MDAIGeneral

Gett and Rosecliff Acquisition Corp agree to terminate the business combination agreement; Gett maintains a path to profitability. Gett and Rosecliff completed a strategic business review, mutually agreeing to terminate

Gett and Rosecliff Acquisition Corp agree to terminate the business combination agreement; Gett maintains a path to profitability. LONDON, United Kingdom, Mar. 11, 2022 - Gett, a leading corporate ground transportation management (GTM) technology platform, and Rosecliff Acquis

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MDAI
Nov 10, 2021
MDAIGeneral

GETT - Category Leading, Corporate Ground Transportation Management Platform to List on NASDAQ Through Merger with Rosecliff Acquisition Corp. Gett is a technology platform focused on corporate Ground Transportation Mana

Ground Transportation Management Platform List on NASDAQ Through Merger with Rosecliff Acquisition Corp. York, NY, and London, UK - November 10, 2021 - Rosecliff Acquisition Corp I (NASDAQ: RCLF) ("Rosecliff"), a special purpose acquisition company, and GT Gettaxi Limited ("Ge

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MDAI
Jun 4, 2021
MDAIGeneral

Rosecliff Acquisition Corp I Receives Expected Notice from Nasdaq Regarding Delayed Filing of Quarterly Report

Acquisition Corp I Receives Expected Notice from Nasdaq Regarding Delayed Filing of Quarterly Report YORK, June 4, 2021 -- On April 12, 2021, the Acting Director of the Division of Corporation Finance and Acting Chief Accountant of the U.S. Securities and Exchange Commission (

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MDAI
Mar 26, 2021
MDAIGeneral

Rosecliff Acquisition Corp I Announces the Separate Trading of its Class A Common Stock and Redeemable Warrants Commencing on or about

Rosecliff Acquisition Corp I Announces the Separate Trading of its Class A Common Stock and Redeemable Warrants Commencing on or about March 26, 2021 NEW YORK, NEW YORK, March 25, 2021 - Rosecliff Acquisition Corp I (Nasdaq: RCLFU) (the "Company") today announced that, commenc

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MDAI
Feb 11, 2021
MDAIGeneral

Rosecliff Acquisition Corp I Announces Pricing of Upsized $220 Million Initial Public Offering

Rosecliff Acquisition Corp I Announces Pricing of Upsized $220 Million Initial Public Offering NEW YORK, Feb. 11, 2021 /PRNewswire/ -- Rosecliff Acquisition Corp I (the "Company") announced today that it priced its initial public offering of 22,000,000 units at $10.00 per unit

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MDAI
Sep 23, 2019
MDAIGeneral

Spectral Design and Test Inc., Announces a New Family of MemoryIP Targeted at the 5G Market

SOMERVILLE, N.J., Sept. 23, 2019 (GLOBE NEWSWIRE) -- Spectral Design & Test Inc. (SDT), a leading provider of embedded Memory Development platform is announcing a portfolio of Memory Compilers targeted at 5G applications that include base stations & edge IOT markets. Spectral’s

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MDAI
Aug 29, 2019
MDAIGeneral

Spectral Financial LAUNCHES SOLUTIONS FOR COMPREHENSIVE CRYPTOCURRENCY TRANSACTIONAL SAFETY AND REGULATORY COMPLIANCE SERVICES

Orlando, FL, Aug. 29, 2019 (GLOBE NEWSWIRE) -- (via Blockchain Wire) Spectral Financial, LLC a new firm that strives to reduce risk in the cryptocurrency space by providing transactional safety and regulatory compliance services, announced the launch of its business with the inte

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MDAI
Sep 25, 2018
MDAIGeneral

Spectral introduces NeuralRAM, memory architectures in 14nm FinFET tech node targeted for a wide range of AI algorithms

SOMERVILLE, N.J., Sept. 25, 2018 (GLOBE NEWSWIRE) -- Spectral Design & Test Inc. (SDT) today announced rolling out a family of MemoryIP on the Global Foundries 14nm FinFET process that addresses the needs of the new Artificial Intelligence (AI), Machine Learning and Deep Learning

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