US-based medical technology company EndoSound has received the US Food and Drug Administration (FDA) 510(k) approval for its EndoSound Vision System (EVS).
The EVS is a novel endoscopic ultrasound (EUS) device that attaches to upper gastrointestinal endoscopes and easily integrates into any endoscopy centre’s existing ecosystem.
EUS is a minimally invasive procedure that involves high-frequency sound waves to produce detailed images to help assess the diseases of the pancreas, liver, and gallbladder.
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The EVS is said to advance the EUS procedures with a more economical offering and provide greater access to critical imaging and therapeutic procedures.
EndoSound anticipates that its EVS will shift the site of care to settings like the ambulatory surgery centre (ASC), which is preferred by patients, providers, and payers.
EndoSound president and CEO Stephen Steinberg said: “We are thrilled to receive 510(k) clearance for our EVS, a testament to the dedication and innovation of the entire EndoSound team.
“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.”
The FDA approval follows a Breakthrough Device designation by the US health agency, granted in July 2021, which confirms the safety features of the EVS technology.
The FDA Breakthrough Device designation underlines the EVS’ novel approach to patient safety, cost reduction, and ability to increase accessibility to critical medical care.
EVS is a significant advancement in medical technology and addresses the issue of infections associated with difficult-to-clean endoscope elevators, said the medical device company.
EndoSound is a privately held medical device company based in Portland, Oregon, engaged in developing endoscopic ultrasound technology.
In October last year, EndoSound signed a letter of intent to partner with single-use endoscopy solutions provider AdaptivEndo to improve endoscopy using new advanced technologies.
Under the partnership, the two companies will expand EndoSound’s ultrasound technology into the single-use endoscopy space to enhance the safety of patients and boost access to care.
