FDA grants 510(k) clearance to EndoSound’s add-on endoscopic ultrasound device

The FDA has granted 510(k) clearance to EndoSound for its Vision System, a novel endoscopic ultrasound device that attaches to upper gastrointestinal endoscopes, according to a company release.
Previously granted FDA breakthrough designation in July 2021, the EndoSound Vision System (EVS) is a supplemental device, consisting of an ultrasound beamformer, reusable transducer and disposable mounting kit, which fastens onto a flexible upper GI video endoscope to modify it into an endoscopic ultrasound system.
“We are thrilled to receive 510(k) clearance for our EVS, a testament to the

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