FDA clears non-invasive insomnia-treating device from Neurovalens

The Modius device. [Image courtesy of Neurovalens]Neurovalens announced today that the FDA granted clearance to its Modius Sleep device for treating chronic insomnia.

Belfast, Northern Ireland-based Neurovalens develops non-invasive neurotechnology. The company took part in the MedTech Innovator Accelerator program last year.

Neurovalens designed Modius to deliver non-invasive electrical stimulation to key areas of the brain and nervous system. It eliminates the need for surgically implanted electrodes.

Modius delivers a small, safe electrical pulse to the head for a period of 30 minutes before bed. During this period, users can perform other activities, like watching television or reading. Clearance allows Neurovalens to sell Modius directly to people suffering from chronic insomnia in the U.S. with a prescription.

Neurovalens said data from a “robust” Phase III/pivotal clinical trial in the UK and Ireland supported the FDA nod. It now i…

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