Motus GI Has Submitted A Special 510(K) To The FDA For Market Clearance Of Its Pure-vu Gen 4 Gastro And Colon. A Special 510(K), According To FDA Guidance, Has An Initial Review Usually Within 30 Days Of Receipt
Portfolio Pulse from Benzinga Newsdesk
Motus GI has submitted a Special 510(K) to the FDA for market clearance of its Pure-Vu Gen 4 Gastro and Colon. The FDA usually reviews a Special 510(K) within 30 days of receipt.
September 26, 2023 | 12:19 pm
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
Motus GI has submitted a Special 510(K) to the FDA for market clearance of its Pure-Vu Gen 4 Gastro and Colon. This could potentially lead to a new revenue stream for the company if approved.
The submission of a Special 510(K) to the FDA is a significant step for Motus GI as it seeks market clearance for its Pure-Vu Gen 4 Gastro and Colon. If approved, this could open up a new revenue stream for the company, which could positively impact its stock price. However, the outcome is uncertain until the FDA completes its review.
CONFIDENCE 75
IMPORTANCE 80
RELEVANCE 100