Motus GI Holdings submits special 510k to FDA for Pure-Vu EVS

Motus GI Holdings announced that it has submitted a special 510(k) to the U.S. Food and Drug Administration 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. The Pure-Vu EVS Gen 4 Gastro for upper gastrointestinal procedures and the improved version for the colon each provide significant benefits compared to previous Pure-Vu models and are designed to potentially open new segments of the GI market by introducing new capabilities while also addressing factors that make it easier to work with commercial partners. “The submission of this special 510(k) to the FDA brings us one step closer to being able to commercially launch our next generation system in the U.S. market. Expanding the Pure-Vu platform’s capabilities into supporting upper GI procedures, an area of high unmet patient need, should accelerate the adoption of the Pure-Vu system in the market,” commented Mark Pomeranz, Chief Executive Officer. “Our submission for 510(k) clearance of the Pure-Vu Gen 4 Gastro and Colon is supported by positive preclinical and clinical data collected by some of the top key opinion leaders in both the U.S. and abroad. These data show the value our new platform offers hospitals and patients suffering from a number of indications.”