Neurovalens, a Belfast-based health tech firm, has secured FDA clearance for two devices: Modius Stress and Modius Sleep, aimed at treating anxiety and insomnia respectively.

The company is pioneering in the field with a focus on noninvasive direct stimulation of the vestibular nerve, a novel approach in the medical device industry.

Recent FDA rule changes in 2019 have paved the way for the approval of such noninvasive electrical stimulation devices.

Beyond stress and sleep, Neurovalens is expanding its technology to address obesity-related cardiometabolic risks and PTSD.

Neurovalens is gearing up for a significant Series B funding round, targeting between $40 million and $50 million.

The company is also actively seeking to obtain medical device clearances for its products in the U.K. and EU markets.