Saluda Medical Receives Regulatory Approval for EVA™ Sensing Technology in Europe with recognition in Australia

MINNEAPOLIS, Jan. 8, 2026 /PRNewswire/ -- Saluda Medical, Inc. (ASX:SLD, "Saluda" or the "Company"), a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed-loop neuromodulation platform, announced that, as expected, its next-generation EVA™ Sensing Technology has now received CE certification for commercialization in Europe with recognition of this approval in Australia. This follows FDA approval of EVA in December 2024.

EVA Sensing Technology builds on the Evoke® System, the first closed-loop spinal cord stimulation (SCS) device capable of reading and responding to the spinal cord’s evoked compound action potentials (ECAPs) in real time, enabling truly personalized therapy and optimized patient outcomes.

EVA Sensing Technology automates manual programming steps and objectively scans and analyzes a patient’s spinal cord to deliver therapy with optimized precision. By removing clinical guesswork and anchoring therapy to each patient’s unique spinal cord physiology, EVA Sensing Technology sets a new standard for personalized pain management.

This approval is in line with our expectations and builds on the successful commercialization we’ve seen in the U.S., this expansion allows us to bring a proven technology enhancement to more markets,” said Barry Regan, CEO, Saluda Medical. “This reinforces our commitment to driving innovation and improving outcomes for patients worldwide.

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