Breakthrough Status

EndoSound Vision Ultrasound System Gains Breakthrough Device Designation

September 3, 2021

Endosound’s Vision System, an add-on tool for endoscopes, has received a Breakthrough Device designation from the FDA.

The system consists of an ultrasound beamformer, a reusable transducer and a disposable mounting kit that fastens onto any flexible upper gastrointestinal video endoscope to convert it into an endoscopic ultrasound system.

The device enables endoscopists to perform advanced procedures, such as fine-needle biopsies without using the elevator mechanisms found on most linear echo-endoscopes. The elevators — which raise and lower accessories passed through the working channel of endoscopes — have come under scrutiny in recent years for the increased risk of patient infections.

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