Hospital Management

Neurovalens receives EU MDR compliance for sleep insomnia device

Achieving MDR compliance shows Modius Sleep meets safety, clinical, and quality standards required for entry into the EU market.

Northern Irish company Neurovalens has received the EU Medical Device Regulation (MDR) compliance for its prescribed insomnia device, Modius Sleep.

This product is now approved for sale in Europe and the UK.

Neurovalens develops non-invasive medical devices targeting various health issues, focusing on at-home treatments for metabolic and mental health.

Known as electrical vestibular system stimulation (VSS), its Modius technology utilises low-level electrical signals to stimulate specific brain regions associated with mental health non-invasively.

Modius Sleep is designed to address insomnia by applying a safe electrical pulse to the user’s head for 30 minutes before bedtime. During treatment, users may continue other activities such as reading or watching television.

Achieving MDR compliance demonstrates that Modius Sleep meets stringent safety, clinical evaluation, and quality management standards required for entry into the EU market.

The device is also registered with the UK Medicines and Healthcare products Regulator Agency (MHRA), making it compliant for sale throughout both the EU and UK.

Previously, Neurovalens gained clearance from the US Food and Drug Administration (FDA) for both Modius Sleep and Modius Calm, its anxiety management device.

Following regulatory clearances, these devices are now prescribed by US healthcare professionals.

Neurovalens CEO Dr Jason McKeown 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.

“Most other sleep-related products on the market measure the symptoms of insomnia, but Modius Sleep is a non-invasive device that actually treats the underlying issue, which can have a transformative impact on the lives of our patients.”

In April 2024, Neurovalens secured clearance from the FDA for its Modius Stress device, designed to treat generalised anxiety disorder.