Motus receives FDA clearance to commercialize Pure-Vu EVS Gastro, Gen 4 Colon

Motus GI Holdings announced that it has received clearance from the U.S. Food and Drug Administration, FDA, for the special 510(k) for technological advancements featured in the new Pure-Vu EVS Gastro and Gen 4 Colon system. The Pure-Vu EVS Gastro opens the critically important upper gastrointestinal portion of the market and access to the high acuity patients that suffer from an upper GI bleed where visualization to address this high mortality condition can be a significant issue. “We are excited to receive FDA clearance for our next generation system, which features key enhancements such as a larger and more powerful suction channel, more efficient irrigation jets, and a smaller profile distal tip that offers enhanced flexibility during insertion and enhanced navigation. In addition to offering new capabilities, this latest version of our platform reduces the cost-of-goods by approximately 50% and the training requirements for the customer from hours to minutes. Based on physician feedback, we expect the Upper GI indication and these enhancements to be well received by the GI community and we believe will drive greater market adoption of the Pure-Vu EVS platform,” commented Mark Pomeranz, Chief Executive Officer. “We look forward to initiating market introduction of the Pure-Vu EVS Gastro and Gen 4 Colon in the U.S. by the end of the year. Currently, we are planning to ramp up manufacturing supply and expect to have supply of both new products to customers in the coming months.”