FDA OKs EndoSound’s Vision System for Endoscopic Ultrasound

EndoSound has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its EndoSound Vision System (EVS), following breakthrough status granted in July 2021.
 
EVS is an endoscopic ultrasound (EUS) that attaches to upper gastrointestinal endoscopes. The company said it easily integrates into an endoscopy center’s existing ecosystem. EndoSound also said the EVS can offer better access to the critical imaging and therapeutic procedure than conventional EUS equipment and expects it will shift the site of care to the ambulatory surgical center (ASC). (Currently, over 95% of patients who undergo EUS are seen in a hospital setting.)
 
To assess diseases of the GI tract and other nearby organs and tissues, EUS uses high-frequency sound waves to generate detailed images of the pancreas, liver, and gallbladder. The EVS also addresses the issue of infections associated with difficult-to-clean endoscope elevators, EndoSound claimed.
 
“We are thrilled to receive 510(k) clearance for our EVS, a testament to the dedication and innovation of the entire EndoSound team. This milestone underscores our commitment to advancing medical technology and improving patient outcomes. With the EVS, we aim to not only enhance the safety of endoscopic procedures but also contribute to expanding access to care for patients worldwide,” said Dr. Stephen Steinberg, president and CEO at EndoSound.
 
Last March, EndoSound received an investment from the American Gastroenterological Association’s (AGA) new venture capital fund, GI Opportunity Fund 1.