RedDress’s ActiGraft System for Wounds Gets 510(k) Clearance

RedDress Medical has received FDA 510(k) clearance for its RD2 Ver.02 ActiGraft wound care system.

ActiGraft is for use at the point-of-care to prepare an in vitro blood clot from a small sample of the patient’s own blood, which is then applied to the wound to serve as a protective covering. Once applied, the blood clot supports natural wound healing.

The system can be used to manage wounds, such as leg ulcers, pressure injuries, diabetic ulcers and mechanically or surgically debrided wounds.