Neurovalens Receives FDA Clearance for Anxiety Treatment Device

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Earlier this year, Neurovalens announced the 2022 Rosenman Innovator has received medical device clearance from the FDA to treat anxiety with its Modius Stress device. The Modius Stress is the healthtech company’s second product cleared for use in the US. Neurovalens also closed a $2.65M funding round.

From the press release:

Based in Belfast, Neurovalens is a health-tech company that specialises in combining neuroscience and technology to tackle a range of global health challenges.

The company’s medical devices have been designed to deliver non-invasive electrical stimulation to key areas of the brain and nervous system without the need for surgically implanted electrodes.

Modius Stress is designed to treat anxiety by delivering a small and safe electrical pulse to the head for a period of 30 minutes before bed, during which users can do other activities, such as watching TV or reading.

Dr Jason McKeown, CEO of Neurovalens, said “Having the Modius Stress technology as a certified medical device for the treatment of generalised anxiety disorder is the next meaningful step for the company as we focus on continued growth in the US market. GAD affects an estimated 6.8 million adults in the US, over 3% of the population, with women twice as likely to be affected as men, according to the American Depression and Anxiety Association. Modius Stress is a non-invasive device that treats the underlying issue to improve the lives of patients. We believe that the low risk, non-invasive therapeutic intervention offered by Neurovalens technology will be truly transformative for a range of serious medical conditions and this latest clearance moves us further towards that goal.”