EndoFresh today said it received FDA 510(k) clearance for its disposable digestive endoscopy system.
The system features a camera system with an all-in-one design, disposable upper GI endoscope and disposable colonoscope, which can be used with the company’s medical display and other peripheral devices for physicians to visualize, diagnose and operate gastrointestinal endoscopy.
“With this novel system, medical practitioners could offer patients a secure experience, which is available at any time and anywhere. It helps to prevent the risk of cross-infection and minimize the workload in preoperative screening and postoperative disinfection,” CEO Dr. Lee said in a news release.
Endoscopes are important medical devices that have been tough to reprocess in the past. Reprocessing failure could result in one person’s tissue or fluid remaining on the scope and going into someone else. The FDA recommended in July 2020 that hospitals and endoscopy facilities consider using disposable scopes to lower the risk of infection.
EndoFresh is one of a handful of single-use endoscope designs that are saving lives. Boston Scientific and Ambu make fully disposable endoscopes, while Olympus, Pentax and GI Scientific make disposable, protective components for endoscope end caps.