EndoSound Secures FDA Clearance For Endoscopic Ultrasound Technology

Republished By Plato

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The device received FDA breakthrough device designation in July 2021. Image credit: Shutterstock/Peter Porrini.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to EndoSound’s Vision system, an endoscopic ultrasound device.

Endoscopic ultrasounds are minimally invasive procedures that use ultrasound to assess the upper gastrointestinal tract. High-frequency sound waves produce detailed images of the pancreas, liver, and gallbladder. The procedure is often utilised to diagnose different types of cancers.

EndoSound’s device attaches to endoscopes, with the company saying that it integrates into existing clinical workflows.

The company states that the design of its technology transforms any flexible upper endoscope into a functional endoscopic ultrasound scope.

According to EndoSound, the device, which received breakthrough device designation from the FDA in July 2021, provides a more economical offering. It also addresses infections associated with difficult-to-clean elevators.

The device is expected to undergo a controlled market release in early Q1 2024.

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More than 95% of patients undergoing endoscopic ultrasounds are seen in hospitals. EndoSound expects its device could help shift the site of care to settings such as ambulatory surgery centres.

A market model by GlobalData placed the endoscopy visualisation systems and components global market at $2.4bn in 2023. By 2033, this is forecast to grow to $3.9bn. Fujifilm, Stryker, and Olympus dominate the market with global shares of 16.6%, 16.2%, and 13.6% respectively.

EndoSound CEO Dr Stephen Steinberg said: “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.”

In October 2023, EndoSound partnered with AdaptiveBio to develop a single-use endoscopy device capable of simultaneous endoscopic ultrasound (EUS)/endoscopic retrograde cholangiopancreatography (ERCP) procedure.

In September 2023, Limaca Medical received FDA clearance for its endoscopic ultrasound biopsy device for definitive pancreatic cancer and gastrointestinal cancer diagnoses.