Cedar Valley, Pa.-based Olympus received FDA 510(k) clearance of claims for its Endocuff endoscopic device.
Here's what you need to know.
1. The device is designed to improve adenoma detection rates during a colonoscopy over standard colonoscopy.
2. Peer-reviewed studies are still required for the Endocuff Vision, a device Olympus recently launched.
3. The material, hinge design and moment of force are similar among the two devices.
4. An FDA analysis determined that Endocuff results in a "statistically and clinically relevant improvement in adenoma detection rate, as compared to unassisted colonoscopy." The analysis was based on several multi-center studies.