EndoSound secures FDA clearance for endoscopic ultrasound technology

The US Meals and Drug Administration (FDA) has granted 510(ok) clearance to EndoSound’s Imaginative and prescient system, an endoscopic ultrasound system.

Endoscopic ultrasounds are minimally invasive procedures that use ultrasound to evaluate the higher gastrointestinal tract. Excessive-frequency sound waves produce detailed photos of the pancreas, liver, and gallbladder. The process is usually utilised to diagnose several types of cancers.

EndoSound’s system attaches to endoscopes, with the corporate saying that it integrates into current scientific workflows.

The corporate states that the design of its know-how transforms any versatile higher endoscope right into a practical endoscopic ultrasound scope.

In accordance with EndoSound, the system, which acquired breakthrough system designation from the FDA in July 2021, supplies a extra economical providing. It additionally addresses infections related to difficult-to-clean elevators.

The system is anticipated to endure a managed market launch in early Q1 2024.

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Greater than 95% of sufferers present process endoscopic ultrasounds are seen in hospitals. EndoSound expects its system might assist shift the location of care to settings akin to ambulatory surgical procedure centres.

A market model by GlobalData positioned the endoscopy visualisation techniques and elements world market at $2.4bn in 2023. By 2033, that is forecast to develop to $3.9bn. Fujifilm, Stryker, and Olympus dominate the market with world shares of 16.6%, 16.2%, and 13.6% respectively.

EndoSound CEO Dr Stephen Steinberg stated: “With the EVS, we goal to not solely improve the protection of endoscopic procedures but additionally contribute to increasing entry to take care of sufferers worldwide.”

In October 2023, EndoSound partnered with AdaptiveBio to develop a single-use endoscopy system able to simultaneous endoscopic ultrasound (EUS)/endoscopic retrograde cholangiopancreatography (ERCP) process.

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


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