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.
“The EndoSound Vision System removes significant patient safety concerns that have been connected with the elevator mechanism over the last several years,” Dr. Shyam S. Varadarajulu, medical director of the Digestive Health Institute at Orlando Health, said in a news release. “In addition to reducing risk, the system features a disruptive price point that gives it the potential to dramatically expand the availability of this critical modality in the United States and around the world.”