Neurovalens earns European and UK approval for non-invasive neuromodulation device
Summary
Neurovalens received both European CE mark and UK MHRA approval for their non-invasive neuromodulation device, expanding their regulatory footprint across two major markets simultaneously. Neurovalens develops devices that target the vestibular system to modulate central nervous system function, with existing FDA-cleared products for insomnia and postoperative nausea. The European and UK approvals enable direct sales to NHS and European hospital systems.
Why it matters
Simultaneous CE mark and UK MHRA approval is an efficient regulatory strategy post-Brexit. For Neurovalens, whose vestibular neuromodulation approach sits at the intersection of sleep, metabolism, and neurological health, European approval expands the addressable market and validates their technology across multiple regulatory jurisdictions for future US FDA interactions.
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