Suneva Medical’s and Bimini Health’s Gel Tube Cleared by FDA

Suneva Medical has received the FDA’s 510(k) clearance for a 30 mL version of its Amplifine PRP (platelet-rich plasma) gel tube.

Headquartered in San Diego, Calif., Suneva is focused on products for regenerative aesthetics, including use of the body’s own restorative capacity to address the impact of aging.

PRP is a regenerative treatment that enables providers to use the patient’s own growth factors by taking a small amount of the patient’s blood and using a centrifuge to separate out the red and white blood cells. The Amplifine tubes use a proprietary gel designed to capture a high concentration of platelets in a short processing time.

Suneva’s partner Bimini Health Tech also announced that Canada’s Medical Devices Directorate has approved its Dermapose fat transfer syringe, which is used in cosmetic procedures to reinject a patient’s fat.