Saluda’s Market Expansion Hinges on EVA™ Commercial Success Post-Approval
Saluda Medical has received CE certification for its EVA™ Sensing Technology, enabling commercialisation in Europe and recognition in Australia following prior FDA approval. This milestone sets the stage for a broader rollout of its personalised spinal cord stimulation therapy in early 2026.
- EVA™ Sensing Technology gains CE certification for Europe
- Regulatory recognition extends to Australia
- Technology automates and personalises spinal cord stimulation
- Limited commercial release planned for Q1 2026
- Builds on prior FDA approval from December 2024
Regulatory Milestone Achieved
Saluda Medical, a commercial-stage medical device company specialising in neuromodulation therapies for chronic neurological conditions, has announced a significant regulatory achievement. Its next-generation EVA™ Sensing Technology has received CE certification, authorising its commercialisation across Europe. This approval also carries recognition in Australia, marking an important expansion beyond the United States, where the technology was approved by the FDA in December 2024.
Advancing Personalised Pain Management
The EVA™ Sensing Technology enhances Saluda’s flagship Evoke® System, the first closed-loop spinal cord stimulation device capable of real-time monitoring and response to neural signals. By automating previously manual programming steps and objectively analysing spinal cord activity, EVA™ delivers therapy tailored to each patient’s unique physiology. This innovation promises to reduce clinical guesswork and improve patient outcomes in managing chronic pain.
Commercial Rollout and Market Impact
Saluda plans a limited commercial release of EVA™ in Europe and Australia starting in the first quarter of 2026, with a full commercial launch to follow later in the year. This timeline aligns with the company’s internal expectations and builds on positive clinical results published in leading medical journals. The expansion into these new markets not only broadens Saluda’s geographic footprint but also reinforces its position as an innovator in neuromodulation therapy.
Expert Endorsements and Clinical Validation
Medical experts, including Dr. Harold Nijhuis from the Antonius Hospital in the Netherlands, have praised EVA™ for delivering objective neural metrics that correlate with maximum pain relief. The technology also streamlines programming, enhancing efficiency for clinicians and improving the overall patient experience. These endorsements underscore the potential for EVA™ to set a new standard in personalised chronic pain treatment.
Looking Ahead
While the regulatory approvals mark a critical step forward, the true test will be how quickly and effectively Saluda can penetrate these new markets and translate technological innovation into commercial success. Investors and industry watchers will be keen to monitor sales uptake and any further regulatory developments as the rollout progresses.
Bottom Line?
Saluda’s CE approval for EVA™ opens new markets, but commercial traction will define its next chapter.
Questions in the middle?
- How rapidly will Saluda scale EVA™ adoption across Europe and Australia?
- What competitive responses might emerge in the neuromodulation device market?
- Will further regulatory approvals in other regions follow soon after?
