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Medical Devices / Submissions and Approvals

FDA Permits de novo Clearance for AirXpander’s Tissue Expander System

Dec. 28, 2016

AirXpanders has received FDA de novo clearance for the AeroForm tissue expander system, a Class II medical device used for breast reconstruction.

AeroForm is activated by a handheld wireless controller that administers small amounts of carbon dioxide to gradually stretch the tissue to prepare for a breast implant.

Aerform is a minimally-invasive device designed for patients who chose reconstructive surgery after a mastectomy.

AeroForm launches January 2017 in the U.S. — Cynthia Jessup

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