FDA Approves Ultrasound Device that Attaches to Endoscopes

It integrates into any endoscopy center’s existing ecosystem.

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EndoSound Inc., a pioneering medical technology company dedicated to advancing patient care, is pleased to announce it has received 510(k) clearance from the FDA for its EndoSound Vision System (EVS). This milestone achievement follows the company’s FDA Breakthrough Device designation in July 2021, emphasizing the technology’s safety features and its potential to enhance access to patient care.The EVS is a novel endoscopic ultrasound (EUS) device that attaches to upper gastrointestinal endoscopes. It integrates into any endoscopy center’s existing ecosystem. With a more economical offering, the EVS can provide greater access to this critical imaging and therapeutic procedure than conventional EUS equipment. EndoSound expects the EVS will shift the site of care to more efficient settings like the ambulatory surgery center (ASC) preferred by patients, providers, and payers.

Breakthrough Technology

The FDA’s Breakthrough Device designation recognized the EVS for its groundbreaking approach to patient safety, cost reduction, and ability to increase accessibility to critical medical care. The EVS represents a significant leap forward in medical technology, specifically addressing the critical issue of infections associated with difficult-to-clean endoscope elevators. This clearance validates the system’s effectiveness and safety, underscoring EndoSound’s commitment to advancing healthcare through innovation.

Endoscopic Ultrasound Procedure

Endoscopic Ultrasound (EUS) is a minimally invasive procedure performed to assess diseases of the GI tract and other nearby organs and tissues. High-frequency sound waves produce detailed images of the pancreas, liver, and gallbladder. Currently, over 95% of patients who undergo EUS are seen in a hospital setting. A majority of those patients could be seen in a more efficient setting where patients prefer to be treated, an ASC.

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