Anti-anxiety device authorized in the USA

Neurotech startup Neurovalens, based in Belfast, Northern Ireland, has received clearance from the Food and Drug Administration (FDA) for its innovative non-invasive anxiety treatment device, Modius Stress. This achievement represents a significant milestone for the company, which has been dedicated to developing technology designed to provide non-invasive electrical stimulation of the brain and nervous system for over a decade.

The FDA authorization is the result of a rule change implemented in 2019 that sought to encourage innovations targeting insomnia and anxiety. With this new authorization, Neurovalens now has two medical devices approved for prescribing by physicians in the United States: one designed to treat generalized anxiety disorder (GAD) and the other targeting insomnia.

Additionally, the company has ambitious plans to develop new products, including a device aimed at treating obesity-related cardiometabolic risk factors and another targeting post-traumatic stress disorder (PTSD).

The startup’s CEO, Dr. Jason McKeown, highlighted the company’s strategic focus on developing regulatory-approved medical devices for specific conditions, distinguishing them from consumer devices that rely on vague “wellness” promises. This approach involves conducting rigorous clinical trials to demonstrate efficacy and safety, ensuring that Neurovalens products are recognized as legitimate medical treatments.

As a consumer device, we would not be allowed to make medical claims. So it’s really about differentiating ourselves as a legitimate medical treatment for very, very specific conditions.

Dr. Jason McKeown, CEO of Neurovalens

Neurovalve Devices

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Source: Olhar Digital