Neurovalens has received FDA approval for its PTSD device, paving the way for the Northern Irish company to expand sales in the US.
The Belfast group has secured De Novo approval from the US Food and Drug Administration 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 device on prescription to veterans through the US Department of Veterans Affairs from July.
Greater access to US sales is a major step for any health tech company, with the US one of the world’s largest medical markets.
Dr Jason McKeown, chief executive of Neurovalens, said: “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.
“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.”
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