Neurovalens, a Northern Irish tech startup developing wearable non-invasive neurological treatments, is set to expand its sales overseas after securing US regulatory approval.
The Belfast group has secured De Novo approval from the US Food and Drug Administration (FDA) for its technology designed to treat post-traumatic stress disorder.
The system works by using low-level electrical signals to stimulate areas of the brain that influence stress responses.
Neurovalens plans to roll out the devices on prescription to veterans through the US Department of Veterans Affairs from July.
Greater access to US sales is a huge step for any health tech, with the States being one of the world’s largest medical markets.
“Neurovalens remains on a mission to offer low risk, non-invasive treatments for chronic health issues such as PTSD. By focusing on a treatment that addresses the underlying cause, we know this can have a transformative impact on the lives of patients,” said Dr Jason McKeown, chief executive of Neurovalens.
“Being granted medical device regulatory approval for Modius Spero from the FDA validates it as a treatment for patients who suffer from PTSD, and is a significant milestone for the company. As a business founded in Northern Ireland, a post-conflict society, it has always felt incredibly meaningful that our device is being used to treat people who have experienced severe trauma.”
