Endosound wins breakthrough device designation for add-on ultrasound system for endoscopes

The EndoSound Vision System [Image courtesy of Endosound]FDA has granted breakthrough device designation to Endosound’s system to turn any flexible upper gastrointestinal video endoscope into an endoscopic ultrasound system.

The EndoSound Vision System is an add-on device that includes a compact ultrasound beamformer, reusable transducer and disposable mounting kit.

Portland, Oregon–based EndoSound touts the system’s distal attachment that allows the endoscopist to perform advanced procedures, such as fine-needle biopsy, with precision. The attachment does not include an elevator mechanism — a problematic feature for endoscopic systems in recent years because of difficulty in cleaning and sterilization.

FDA, in fact, has been calling for more single-use endoscopes or scope tips to reduce potentially deadly superbug infections. The breakthrough device designation could expedite the regulatory evaluation of the EndoSound Vision System.


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