Northern Ireland-based medical technology company Neurovalens has secured EU and UK approval for its Modius Sleep device, according to the Belfast News Letter.

The approval enables the non-invasive neurostimulation device to be sold across both markets, subject to prescription requirements.

The device meets EU Medical Device Regulation (MDR) requirements covering safety, clinical evaluation, and quality management, and is also registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA). This aligns the product with strict health and safety standards in both jurisdictions.

Modius Sleep uses low-level electrical signals to stimulate areas of the brain linked to sleep regulation. It is designed as a drug-free option for insomnia, with sessions lasting around 30 minutes before bed.

Neurovalens has previously received US Food and Drug Administration clearance for Modius Sleep and its anxiety-focused device, Modius Calm. The products are prescribed in the United States and used within clinical settings.

Dr Jason McKeown, chief executive of Neurovalens, said: “Receiving this approval for the Modius Sleep from EU and UK regulators is another significant landmark for Neurovalens as we continue on our mission to offer a low risk, non-invasive therapeutic alternative to the existing treatments for chronic health issues such as insomnia and anxiety.”

He added that the device targets underlying causes rather than symptoms, while approvals in Europe and the UK open additional commercial pathways.

Modius Sleep is available via prescription in the US at $2,265 (€1958.75) and is also accessible to US veterans through the Department of Veterans Affairs. The company has raised around £20m (€17.30m) from investors including the British Business Bank and several venture capital firms.

Neurovalens continues to conduct clinical trials on its non-invasive technology, with approvals also pending for the treatment of post-traumatic stress disorder.

Read the full report for more on how regulatory approval is shaping the rollout of non-invasive health and safety technologies.