www.fdanews.com/articles/179825-fda-permits-de-novo-clearance-for-airxpanders-tissue-expander-system
FDA Permits de novo Clearance for AirXpander’s Tissue Expander System
December 23, 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