The FDA granted 510(k) clearance to a smooth shell version of AirXpander’s AeroForm Tissue Expander, a device used in breast reconstruction.

The device is placed behind the patient’s chest similar to saline-filled expanders, but uses a wireless, handheld dosage controller for expansion instead of saline solution injection.

The expander reduces the number of visits to physicians and lowers the amount of time it takes for breast expansion procedures.