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Profound Medical Receives U.S. FDA 510(k) Clearance for TULSA-PRO® Thermal Boost

Key Takeaway: Profound Medical has announced that it has received 510(k) clearance from the U.S. FDA for its TULSA-PRO® Thermal Boost system. This clearance allows the company to market the device, which is expected to improve treatment options for patients. The approval represents a significant advancement in the company's product offerings.
Price reaction · baseline $8.5 (2024-02-16 close) · clean, no other PROF news in the window
day 0 close · peak
-2.7%

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POSITIVE FACTORS

  • Profound Medical received FDA clearance for TULSA-PRO®.
  • This approval may enhance treatment options for patients.
  • The clearance signifies a step forward in medical technology.

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Company

Profound Medical Corp. 2400 Skymark Avenue Unit 6 Mississauga, ON L4W 5K5 Canada

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Computershare Trust Company, N.A. (U.S.) 118 Fernwood Avenue Edison, NJ 08837 United States of America T: 732-417-2700
TSX Trust Company (Canada) 301-100 Adelaide Street West Toronto, ON M5H 4H1 Canada T: 866-600-5869

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Frequently Asked Questions

What is TULSA-PRO®?

TULSA-PRO® is a thermal boost system developed by Profound Medical.

What does FDA 510(k) clearance mean?

FDA 510(k) clearance indicates that a medical device is safe and effective for its intended use.

How does TULSA-PRO® improve treatment options?

TULSA-PRO® enhances treatment options by providing advanced thermal therapy.

Who is Profound Medical?

Profound Medical is a company focused on innovative medical technologies.

Last updated: Feb 19, 2024