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Medical Devices / Submissions and Approvals

FDA Awards Lumendi Marketing Clearance for DiLumen

Dec. 14, 2016
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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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