Olympus’ Endocuff receives FDA 510(k) clearance of claims: 4 notes

Cedar Valley, Pa.-based Olympus received FDA 510(k) clearance of claims for its Endocuff endoscopic device.

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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.

More articles on gastroenterology/endoscopy:
Olympus, Boston Scientific & more — 3 GI company key notes
GI leader to know: Dr. Eric Osgard of Gastroenterology Consultants
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