EndoSound Inc announced that 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.

The EVS is a novel endoscopic ultrasound (EUS) device that attaches to upper gastrointestinal endoscopes. It easily 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, according to the company. 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.

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, according to the company.

“We are thrilled to receive 510(k) clearance for our EVS, a testament to the dedication and innovation of the entire EndoSound team,” said Stephen Steinberg, MD, president and CEO at EndoSound. “This milestone underscores our commitment to advancing medical technology and improving patient outcomes. With the EVS, we aim to not only enhance the safety of endoscopic procedures but also contribute to expanding access to care for patients worldwide
Breakthrough Technology.”

The FDA’s Breakthrough Device designation recognized the EVS for its approach to patient safety, cost reduction, and ability to increase accessibility to critical medical care. The EVS specifically addresses the critical issue of infections associated with difficult-to-clean endoscope elevators. The clearance validates the system’s effectiveness and safety, underscoring EndoSound’s commitment to advancing healthcare through innovation, according to the company.