Posted by Michael Wonder on 01 Sep 2021
U.S. FDA grants breakthrough device designation for innovative EndoSound vision ultrasound system
1 September 2021 - Endosound announced today that its EndoSound Vision System received a Breakthrough Device Designation from the U.S. FDA.
The EndoSound Vision System is an add-on device that consists of a compact ultrasound beamformer, reusable transducer, and disposable mounting kit that fastens onto any flexible upper gastro-intestinal video endoscope to convert it into an endoscopic ultrasound system. Its unique distal attachment allows the endoscopist to perform advanced procedures, such as fine needle biopsy, with precision, but without the controversial elevator mechanism found on most other linear echo-endoscopes.
