The EndoSound Vision System was granted breakthrough device designation by the FDA Sept. 1.
The add-on device transforms a flexible upper gastrointestinal video endoscope into an endoscopic ultrasound system, allowing endoscopists to perform advanced procedures without the risk of patient infections often associated with other multiuse endoscopes.
The FDA designation expedites the development and evaluation of selected devices.
Endosound is based in Portland, Ore.