FDA-Cleared Nerve Stimulator Advances Intraoperative Peripheral Nerve Assessment

The device has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The clearance represents an expansion of the company’s portfolio and commercial footprint for its bioelectronic platform in peripheral nerve care.

Evala operates by delivering controlled electrical stimulation during surgery to help differentiate neural structures and assess functional responses in real time. The design emphasizes speed and accuracy to support intraoperative decision-making, including evaluation of both large and small-caliber nerves. Early clinical use scenarios cited for the system include revision procedures, nerve transfers, and cases performed under extended tourniquet time.

The company positions Evala as part of a broader ecosystem for peripheral nerve care, complementing its PeriPulse platform to support surgeons during the most demanding aspects of procedures. Within this portfolio approach, the technology is described as integrating into surgical workflows to enhance efficiency while addressing intraoperative nerve assessment needs.

“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. Jana Dengler, MD, MASc, MHSc, peripheral nerve surgeon at Sunnybrook Health Sciences Centre.

“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, CEO of Epineuron.

"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,” said Aguirre.

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