EndoSound announced today that it received FDA 510(k) clearance for its EndoSound Vision System (EVS).
Portland, Oregon-based EndoSound designed the EVS endoscopic ultrasound (EUS) device to attach to upper gastrointestinal endoscopes. It easily integrates to any endoscopy center’s existing ecosystem and provides access to both imaging and a therapeutic procedure.
EndoSound believes the EVS could shift the site of care to more efficient settings like ambulatory surgery centers (ASCs). In a news release, the company said labeled EVS as “poised to revolutionize the landscape of EUS). The system initially received FDA breakthrough device designation in 2021