BioTime Receives FDA Premarket Notification Clearance For Premvia™ 510(k)

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ALAMEDA, Calif.--(BUSINESS WIRE)--BioTime, Inc. (NYSE MKT: BTX) today announced that it has received notice from the FDA’s Center for Devices and Radiologic Health that Premvia™ has been cleared for marketing as a Class II medical device. Premvia™ is the first FDA-cleared member of BioTime’s HyStem® family of hydrogels, which are designed to mimic the natural structures of the human body’s extracellular matrix. According to the FDA clearance, the product is indicated for the management of wounds including: partial thickness, full-thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin graft sites, post-Moh’s surgery, post-laser surgery, podiatric wounds, wound dehiscence, abrasions, lacerations, second degree burns, skin tears and draining wounds.

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