Medical device company RedDress Ltd disclosed on Wednesday the receipt of the US Food and Drug Administration's (FDA) 510(k) clearance for its wound care product, RD1 system.
Following the US FDA's 510(k) clearance, the company will now launch its RD1 System device in the US market.
According to the company, RD1 is an innovative wound care product which enables health care providers to produce in real time, in vitro whole blood clots, for use as a chronic wound care product. It has been developed to address the need for cost effectiveness and clinical effectiveness of wound care.
The company added the RD1 System is intended to be used at point-of-care for the safe and rapid preparation of whole blood clot from a small sample of a patient's own peripheral blood. Under the supervision of a healthcare professional, the whole blood clot produced by the RD1 System is topically applied for the management of exuding cutaneous wounds, including leg ulcers, pressure ulcers, diabetic ulcers and mechanically or surgically-debrided wounds.
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