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Profound Medical Receives FDA HDE Approval for Sonalleve®

Monday, February 19, 2024 BiopharmaWatch Research 1 min read
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Key Takeaway: Profound Medical Corp. has announced that its Sonalleve® device has received FDA approval under a Humanitarian Device Exemption for treating osteoid osteoma. This approval represents a significant advancement for the company and provides a new therapeutic option for patients with this condition. The approval is expected to enhance Profound's market presence.
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Market Sentiment Analysis

POSITIVE FACTORS

  • FDA approval for Sonalleve® signifies a major milestone.
  • The device offers a new treatment option for osteoid osteoma.
  • Profound Medical expands its product portfolio with this approval.

Full Press Release Details

TORONTO, Nov. 30, 2020 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”) announced today that Sonalleve® has received U.S. Food and Drug Administration (“FDA”) approval under a Humanitarian Device Exemption (“HDE”) for the treatment of osteoid osteoma.

Frequently Asked Questions

What is Sonalleve® approved for?

Sonalleve® has received FDA approval for the treatment of osteoid osteoma.

What type of FDA approval did Sonalleve® receive?

Sonalleve® received approval under a Humanitarian Device Exemption (HDE).

Which company developed Sonalleve®?

Sonalleve® was developed by Profound Medical Corp.

When did Profound Medical announce the FDA approval?

Profound Medical announced the FDA approval on November 30, 2020.

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Tags: PROF Viatris Investor Conferences Healthcare Profound Medical Sonalleve FDA osteoid osteoma HDE
Last updated: Feb 19, 2024

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