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.
Oculis secures FDA Breakthrough Therapy Designation for Privosegtor in optic neuritis
Esco Aster partners with Shine-On Biomedical for HLA-G targeting exosome drug delivery platform
RedHill advances RHB-102 across GI indications
FDA grants priority review for Sanofi's Tzield in young children with stage 2 type 1 diabetes
ScinoPharm Taiwan secures first US FDA approval for complex multiple sclerosis generic
ScinoPharm Taiwan's Glatiramer Acetate Injection approved by US FDA
Samsung Bioepis begins direct commercialisation of BYOOVIZ in Europe
Corcept announces receipt of FDA Complete Response letter for relacorilant in hypercortisolism
Axsome Therapeutics secures FDA priority review for AXS-05 in Alzheimer's disease agitation
Vanda's NEREUS approved by US FDA for prevention of motion sickness
Diamyd Medical agrees accelerated efficacy readout in ongoing Phase 3 type 1 diabetes trial
INOVIO's INO-3107 Biologics License Application accepted by US FDA
Citius Pharmaceuticals reports full-year financial results
Bioeq and Zydus partner for US commercialisation of Lucentis biosimilar NUFYMCO