The company has received FDA marketing clearance for an enhanced film material used to contain the CO2 within the device.

AeroForm is activated by a handheld wireless controller that administers small amounts of carbon dioxide (CO2) up to three times a day, to gradually stretch the tissue to prepare for a breast implant.

The device is used as a needle-free alternative for women who choose reconstructive surgery following a mastectomy.

AeroForm received de novo clearance from the FDA in December 2016. — Cynthia Jessup