(RTTNews) - Saluda Medical, Inc. (SLD.XA), a commercial-stage medical device company focused on developing treatments for chronic neurological conditions, announced that its next-generation EVA Sensing Technology has received CE certification for commercialisation in Europe, with recognition of this approval in Australia.
A CE certification mark indicates that a medical device complies with the EU Medical Device Regulation requirements for safety, performance, and quality, and it is mandatory to market medical devices throughout the European Union (EU) and European Economic Area (EEA).
Australia and the EU have a Mutual Recognition Agreement (MRA) for medical device conformity assessments. This means that Australia may recognise conformity assessments and certificates issued by EU authorities as evidence that a device meets the Australian requirements.
Also, Saluda is set to release a limited commercial release in Europe and Australia in the first quarter of 2026, followed by a full commercial release later in the year.
FDA approved EVA in December 2024, and the full commercial launch was announced in July 2025.EVA has been utilized in over 3,000 commercial patient visits through a limited market release.
Spinal cord stimulation is a therapy used to treat chronic pain by delivering electrical pulses to the spinal cord for pain management.
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 personalised therapy and optimised patient outcomes.
In addition, EVA Sensing Technology automates manual programming steps and objectively scans and analyzes a patient's spinal cord to deliver therapy with precision.
By removing clinical guesswork and anchoring therapy to patients' unique spinal cord physiology, EVA Sensing Technology may improve personalized pain management.
SLD.XA closed trading at AU$1.17, down 8.04%.
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