Neurovalens

Neurovalens is a company in Belfast, United Kingdom, focused on non-invasive neuro-technology and noninvasive medical devices intended to treat health concerns. Its Modius technology is described as drug-free and non-invasive, and the company states its devices are FDA-authorized and physician prescribed. Founder Dr. Jason McKeown, MD PhD, is a UK-trained medical doctor specializing in non-invasive neurostimulation who led the team through a study into the effectiveness of the Modius Sleep device for chronic insomnia. The company received FDA 510(k) clearance for Modius Sleep in October 2023 and FDA clearance for Modius Calm, a treatment for anxiety, in March 2024. Modius Spero received FDA De Novo approval as a neuromodulation device to treat symptoms associated with PTSD, and Modius Sleep achieved EU Medical Device Regulation (MDR) compliance for sale in Europe and the UK.

Neurovalens is a company in Belfast, United Kingdom. Founder Dr. Jason McKeown, MD PhD, is a UK-trained medical doctor specializing in non-invasive neurostimulation. After years of research and development, Dr. McKeown led the Neurovalens team through a study into the effectiveness of the Modius Sleep device on the treatment of chronic insomnia, resulting in Medical Device Regulatory Approval via FDA 510(k) clearance in October 2023. In March 2024, Neurovalens also received FDA clearance for Modius Calm, a treatment for anxiety. The company's Modius Spero received FDA De Novo approval as the world's first neuromodulation device authorized by the FDA to treat symptoms associated with PTSD. Neurovalens also achieved EU Medical Device Regulation (MDR) compliance for Modius Sleep, its first product approved for sale in Europe and the UK.

Noninvasive medical devices to treat some of the world's greatest health concerns; drug-free and non-invasive neurostimulation.

• Modius Sleep

  A device studied for the treatment of chronic insomnia; received FDA 510(k) clearance in October 2023 and EU MDR compliance.

• Modius Calm

  A treatment for anxiety that received FDA clearance in March 2024.

• Modius Spero

  A neuromodulation device that received FDA De Novo approval to treat symptoms associated with PTSD; available to Veterans with PTSD through the VA.

1. 1Insomnia Relief with Neurostimulator Device – Modius Sleepneurovalens.com
2. 2Neurostimulation Therapy for Anxiety & Sleep Disordersneurovalens.com
3. 3Neurovalens Ltd. (United Kingdom)wikidata.org