MISSISSAUGA, Ontario — Epineuron, a medical device company pioneering bioelectronic medicine, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Evala® Nerve Stimulator. This handheld, intraoperative electrical stimulation device is engineered to provide surgeons with a rapid and accurate solution for nerve identification and functional evaluation of different nerve sizes, large and small. This milestone marks a significant expansion of the company’s portfolio and commercial footprint of its proprietary bioelectronic platform for peripheral nerve care.
Dr. Jana Dengler, MD, MASc, MHSc, a peripheral nerve surgeon at the renowned Sunnybrook Health Sciences Centre in Toronto, ON, was among the early users of Evala®. “I am impressed with the versatility of the product allowing me to evaluate nerves in scarred revision surgeries, nerve transfers, under extended tourniquet time, and in conjunction with PeriPulse,” said Dr. Dengler.