Saluda Medical (ASX:SLD) said its next-generation EVA Sensing Technology product has now received CE certification for commercialization in Europe, with recognition of this approval in Australia, according to a Monday Australian bourse filing.

This follows the US Food and Drug Administration approval of EVA in December 2024, the filing added.

The company said its EVA Sensing Technology automates manual programming steps and objectively scans and analyzes a patient's spinal cord to deliver therapy with optimized precision.

"This approval is in line with our expectations and builds on the successful commercialisation we've seen in the US, this expansion allows us to bring a proven technology enhancement to more markets," said Chief Executive Barry Regan.

The company added that a limited commercial release in Europe and Australia will begin in the first calendar quarter of 2026, followed by a full commercial release later in the year, and the timing of this approval and launch is in line with the company's internal expectations.