Belfast’s Neurovalens achieves FDA clearance for insomnia-treating device

  • By Blathnaid O’Dea.

    Neurovalens, a Belfast-based company that specialises in non-invasive neuroscience-influenced medical devices, has received approval from the US Food and Drug Administration (FDA) for its Modius Sleep product.

    Modius Sleep has been designed to treat chronic insomnia by delivering a small electrical pulse to the head for a period of 30 minutes. Patients wear the device right before they go to bed and they can do activities such as reading or watching television while they receive the treatment.

    The FDA clearance means Neurovalens can now sell the product in the US to patients who have a prescription from their doctor. The FDA arrived at its decision to grant Modius Sleep clearance following a clinical trial that was carried out in the UK and Ireland by Ulster University and in Hong Kong by PolyU University.

    Welcoming the “landmark step for the company”, Neurovalens’ CEO Dr Jason McKeown said the product was part of the company’s focus on using neuroscience and technology to treat patients. “Most other products on the market measure symptoms of insomnia, but Modius Sleep is a non-invasive device that actually treats the underlying issue, improving the lives of our patients,” he said. “We believe that the low-risk, non-invasive therapeutic intervention offered by Neurovalens technology will be truly transformative for a range of serious medical conditions.”

    RELATED: Neurovalens secures place on prestigious MedTech Innovator accelerator

    The approval from the FDA is also a big coup for Neurovalens in terms of its focus on the US market. As well as Belfast, it also has a base in San Diego. Currently, it has approvals pending for drug-free treatment of anxiety and obesity.

    Since it was established in 2015, it has raised approximately £11m in equity funding. Its investors include Wharton Asset Management, IQ Capital, Techstart Ventures, Angel Co Fund, Beltrae Partners, Clarendon Fund Management and British Business Bank. It is hoping to go for a Series B funding round next year.

    Last year, Neurovalens participated in the prestigious MedTech Innovator competition alongside SymPhysis Medical, the latter of which went on to win the event.

    Source: Silicon Republic 2023, "Belfast’s Neurovalens achieves FDA clearance for insomnia-treating device" (

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