Saluda Medical, Inc. (ASX: SLD), an American commercial-stage medical device company, said on Thursday that its next-generation EVA Sensing Technology has received CE certification for commercialisation in Europe, with recognition of this approval in Australia.

The approval follows US Food and Drug Administration clearance granted in December 2024.

EVA builds on the Evoke System, a closed-loop spinal cord stimulation device that reads and responds to evoked compound action potentials in real time, with the goal of enabling personalised therapy and optimised patient outcomes.

The technology automates manual programming and is designed to objectively scan and analyse a patient's spinal cord to deliver therapy with greater precision, reducing clinical guesswork.

Saluda Medical plans a limited commercial release in Europe and Australia in the first calendar quarter of 2026, followed by a full commercial launch later in the year.