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Medical Devices / Submissions and Approvals

FDA Awards Lumendi Marketing Clearance for DiLumen

Dec. 14, 2016

Lumendi has received FDA marketing clearance for DiLumen, an endoscopic device used in the surgical treatment of colon lesions.

DiLumen is a flexible single-use sheath component that attaches to the end of a colonoscope.

During surgery, the sheath expands its two balloons to widen the stomach tubes to create an operable area to treat stomach lesions. — Cynthia Jessup

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