Medical technology developer EndoSound has received 510(k) clearance with breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its EndoSound Vision System (EVS).
The EVS is a new endoscopic ultrasound device that attaches to upper gastrointestinal endoscopes for access to imaging and therapeutic procedures. EndoSound, based in Portland, OR, said it expects the device to be used in settings like the ambulatory surgery center preferred by patients, providers, and payers.
