EndoSound Inc., a medical technology company, has received 510(k) clearance from the FDA for its EndoSound Vision System® (EVS), a novel Endoscopic Ultrasound (EUS) device. This clearance, following the FDA’s Breakthrough Device designation in July 2021, marks a significant advancement in patient care. The EVS attaches to upper gastrointestinal endoscopes and integrates easily into existing endoscopy centers, making EUS more accessible and economical.
It aims to shift the site of care to more efficient settings like ambulatory surgery centers (ASCs), preferred by patients, providers, and payers. The technology is recognized for its patient safety, cost reduction, and increased accessibility to critical medical care, particularly addressing infections associated with difficult-to-clean endoscope elevators. EndoSound plans to begin a controlled market release of the EVS in early Q1 2024.