- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
FDA cleared the TULSA-PRO system for Profound Medical (Canada).
4 reports, 2 independent
Updated Aug 28
Gone quiet
Reached 2 outlets in its first 24 hours
- Reports
- 4
- Developments
- 3
- Repetition
- 25%
New informationRepeats or wire copies
AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.
What happened
FDA cleared the TULSA-PRO system for Profound Medical (Canada).
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.FDA cleared the TULSA-PRO system for Profound Medical.1 source
Profound Medical targets sales for Tulsa Pro in the region.1 source
Profound Medical presented data from the TULSA trials.1 source
Keep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
- A partnership with BARDA has accelerated the development of SCY-247 for the company.
- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- Approval leads to procurement process initiation.
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
The entities involved
- FDA
-
Profound Medical (Canada)
company in Mississauga, Canada
Nothing else this week.
Related events
- FDA approval enables commercial opportunity involving CBRE Group.
- Unregulated products are bypassing official government approval processes.
- The FDA is facing public scrutiny due to oversight failures, leading to the introduction of new legislation targeting agency shortcomings.
- Litigation regarding FDA approval process.
- Ondine Biomedical Inc. is seeking a pre-NDA meeting with the FDA regarding LANTERN results while conducting clinical trials in the US and Canada.
Coverage
Newest first; wire copies grouped- GlobeNewswireProfound Medical to Participate in Lake Street’s 9th Annual Best Ideas Growth Conference TORONTO, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “C
- GuruFocus.comProfound Medical Corp (PROF) Q2 2025 Earnings Call Highlights: Navigating Challenges with ... Release Date: August 14, 2025 For the complete transcript of the earnings call, please refer to the full
- GlobeNewswireProfound Medical Announces Second Quarter 2025 Financial Results TORONTO, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-s
- Unknown outlet