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.