A novel wearable that treats insomnia and anxiety receives FDA approval

Modius Sleep for Insomnia and anxiety

A novel wearable device, Modius Sleep, received FDA approval last week for its ability to help treat insomnia and anxiety.

The wearable, shaped like a headband, comes from Neurovalens, a company working at the forefront to utilize non-invasive cranial nerve stimulation to treat various health conditions.

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About the Modius Sleep wearable

Neurovalens has been working with neuroscience technology to help with some of tsignificantlth problems.

With Modius Sleep, the company created a non-invasive method of stimulating key criticalas of the brain and nervous system and has developed this technology into a range of easy-to-use, wearable devices that deliver the required stimulation in the comfort of your own home.

The key target areas for Neurovalens’ technology are the hypothalamus and the associated autonomic nuclei of the brainstem. These areas regulate metabolic control, stress response, and circadian regulation.

The current FDA 510(K) approval is for treating anxiety and insomnia. You can read about their clinical trial proceedings from this published paper as well as other clinical trials on their website.

FDA Approval for cranial therapy wearable

The UK-based company is also in the process of executing new clinical trials for the device that aim to help people with PTSD and more.

Other companies, including tech giants like Apple, have been exploring new health use cases for their new Vision Pro headset. According to Information, the Cupertino company has discussed using Vision Pro for mental health diagnosis and treatment.

The neurotechnology and wearables area is also seeing new players in sleep wellness, including Bia Sleep, which is introducing a sleep management and monitoring device that uses neurofeedback to help with sleeping problems.

We can definitely expect more products and features in this field in the coming years. The neurofeedback-based technology is beginning to take shape with the advent of specialized headsets and monitoring devices with built-in EEG sensors and more.

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Sudz Niel Kar
I am a technologist with years of experience with Apple and wearOS products, have a BS in Computer Science and an MBA specializing in emerging tech, and owned the popular site AppleToolBox. In my day job, I advise Fortune 500 companies with their digital transformation strategies and also consult with numerous digital health startups in an advisory capacity. I'm VERY interested in exploring the digital health and fitness-tech evolution and keeping a close eye on patents, FDA approvals, strategic partnerships, and developments happening in the wearables and digital health sector. When I'm not writing or presenting, I run with my Apple Watch Ultra or Samsung Galaxy Watch and closely monitor my HRV and other recovery metrics.


  1. “You can read about their clinical trial proceedings from this paper published recently.”

    Nope, that’s a thesis from 1994 🙁


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