FDA Clears Epineuron’s Evala Nerve Stimulator

Bioelectronic medicine company Epineuron has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Evala nerve stimulator.

The handheld, intraoperative electrical stimulation device was designed to offer surgeons with a quick, accurate solution for nerve identification and functional evaluation of different nerve sizes. The company said this milestone is a significant expansion of its 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 Sunnybrook Health Sciences Centre in Toronto, was among the early Evala users.

“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.

“At Epineuron, we’ve listened closely to surgeons that expressed a significant need for more than just nerve stimulation hardware, they needed a cohesive ecosystem for nerve care,” said Sergio Aguirre, Epineuron’s CEO. “We’ve broadened our technology by complementing PeriPulse with Evala to support surgeons during the most demanding aspects of a procedure. Whether it’s protecting nerves in real-time or boosting their regenerative capacity afterward, our technology integrates seamlessly into the surgical workflow to enhance efficiency and offer patients the best path to recovery.”

In May 2025, the company published results from a groundbreaking first-in-human trial of its PeriPulse nerve stimulation in regenerating acutely injured peripheral nerves.