EndoSound® Secures 510(k) Clearance for Breakthrough EVS® Endoscopic Ultrasound Tech

Wednesday, January 03, 2024

EndoSound®, a trailblazing medical technology company dedicated to advancing patient care, is excited to announce the FDA's 510(k) clearance for its groundbreaking EndoSound Vision System® (EVS®). This innovative endoscopic ultrasound (EUS) device, designed to attach to upper gastrointestinal endoscopes, seamlessly integrates into existing endoscopy centers, offering a potential shift towards more efficient settings like ambulatory surgery centers (ASCs).

The EVS is poised to revolutionize the landscape of EUS by providing a cost-effective alternative that enhances access to crucial imaging and therapeutic procedures. The FDA's recognition of the EVS as a Breakthrough Device underscores its commitment to patient safety, cost reduction, and increased accessibility to essential medical care. The clearance solidifies EndoSound's dedication to advancing healthcare through inventive solutions.

EUS is a minimally invasive procedure for assessing diseases of the GI tract and nearby organs and tissues, utilizing high-frequency sound waves to produce detailed images. The EVS's clearance addresses the critical issue of infections related to challenging-to-clean endoscope elevators.

This milestone signifies the system's effectiveness and safety, marking a significant leap forward in medical technology. Currently, over 95% of EUS patients are treated in a hospital setting, and the EVS has the potential to shift the site of care to more efficient ASCs, preferred by patients, providers, and payers.


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