From left: Iain Hendrick, Sinead Watson, Jason McKeown and Chris McCabe. Image: Neurovalens

Other devices developed by the Northern Irish company for the treatment of insomnia, anxiety and weight management have previously received various levels of FDA approval.

Belfast health-tech company Neurovalens has received ‘de novo’ approval from the US Food & Drug Administration (FDA) for its prescribed treatment for symptoms associated with post-traumatic stress disorder (PTSD).

The treatment, a non-invasive medical device named ‘Modius Spero’, is specifically designed to help treat the symptoms of PTSD, according to the company.

It works by stimulating deep parts of the brain, associated with stress response and regulation of mental health, using small and safe electrical pulses – known as electrical vestibular system stimulation – delivered to the skin behind each ear for a period of 30 minutes daily, its maker said.