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Home » Epineuron wins FDA clearance for nerve stimulator

Epineuron wins FDA clearance for nerve stimulator

May 13, 2026 By Sean Whooley

Epineuron Evala nerve stimulator
The Evala nerve stimulator [Image from Epineuron]
Epineuron announced today that it received FDA 510(k) clearance for its Evala nerve stimulator technology.

Mississauga, Ontario-based Epineuron designed its handheld, intraoperative Evala electrical nerve stimulation device to provide surgeons with a rapid and accurate solution for nerve identification and functional evaluation of different nerve sizes, both large and small.

Epineuron said FDA clearance marks a significant expansion of its portfolio. It also expands the commercial footprint of its proprietary bioelectronic platform for peripheral nerve care.

Dr. Jana Dengler, a peripheral nerve surgeon at Sunnybrook Health Sciences Centre in Toronto, served as an early user of Evala. Dengler said the technology enables the evaluation of nerves in scarred revision surgeries, nerve transfers, under extended tourniquet time and in conjunction with PeriPulse, Epineuron’s device that sends electrical impulses directly to the damaged nerve during or shortly after surgery.

Epineuron said its portfolio expansion reflects its dedication to delivering bioelectronic advancements to peripheral nerve care.

“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 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.”

Epineuron was one of 50 startups named in MedTech Innovator’s 2022 cohort.

Filed Under: 510(k), Bioelectronic Medicine, Food & Drug Administration (FDA), Neurological, Neuromodulation/Neurostimulation, Regulatory/Compliance Tagged With: Epineuron, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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