Article taken from: https://www.massdevice.com/fda-clears-insomnia-treating-device-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 intends to enter talks with insurance providers to pick up reimbursement in the U.S.
“Having the Modius Sleep technology as a certified medical device for the treatment of chronic insomnia is a landmark step for the company as we focus on future growth in the U.S. market,” said Neurovalens CEO Dr. Jason McKeown. “Most other products on the market measure symptoms of insomnia, but Modius Sleep is a non-invasive device that actually treats the underlying issue, improving the lives of our 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, having carried out extensive clinical trials in the U.S. and Northern Ireland, we’re really excited to be moving to this next stage.”