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Neurovalens decks £2.1M funding and FDA clearance: A spotlight on 5 mental health wearables competing in Europe

Neurovalens decks £2.1M funding and FDA clearance: A spotlight on 5 mental health wearables competing in Europe
Image credit: Neurovalens

Belfast-based health-tech startup Neurovalens has recently made significant strides in the fight against anxiety. The company secured a £2.1 million ($2.65 million) funding round and received clearance from the US Food and Drug Administration (FDA) for their Modius Stress headband, a wearable device utilising electronic brain stimulation for anxiety treatment. It is to be noted that Modius Stress is the company’s second FDA-approved product after the Modius Sleep device for insomnia.

In the same line, back in February, one startup raised $2.3M to tackle PMS and period pain using neurotechnology wearable device. Also, last month, startup building biowearables for CKD, bagged €2.3M for clinical trials.

The new investments were raised from previous investors including MedTech Innovator, Invest Northern Ireland, Techstart Ventures, Angel Co Fund, Beltrae Partners, Clarendon Fund Management, British Business Bank, IQ Capital and Wharton Asset Management.

Founded in 2016 by Dr. Jason McKeown and Dr. David Kennedy, Neurovalens focuses on utilising neuroscience to tackle various health issues. Their flagship product, the Modius Stress headband, delivers gentle electrical pulses to the head during 30-minute sessions, ideally used before sleep. 

This FDA-approved medical device targets generalised anxiety disorder (GAD), a condition affecting millions worldwide. The recent funding round, according to Neurovalens, is a crucial step for them to reach more people struggling with GAD.

The impact of GAD and Neurovalens’ solution

GAD is a significant public health concern, especially in the US. Dr. Jason McKeown said that 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. This emphasises the need for accessible and effective solutions. Neurovalens positions Modius Stress as a non-invasive device that addresses the underlying issue of anxiety, aiming to improve the lives of a significant portion of the population.

Beyond the immediate impact on GAD treatment, Neurovalens believes their technology has broader potential. The company states that the “low risk, non-invasive therapeutic intervention offered by Neurovalens technology will be truly transformative for a range of serious medical conditions.” This FDA clearance for Modius Stress is seen as a stepping stone towards achieving that goal.

Neurovalens’ competition in the European market

However, Neurovalens is alone in this space. The mental health wearables market is experiencing a surge in popularity, offering non-invasive and accessible solutions for anxiety, stress, and sleep issues. Here’s a closer look at some of Neurovalens’ competitors:

Muse Headband 

This headband uses EEG (electroencephalography) technology to monitor brainwaves and provide real-time feedback through guided meditations and games. While not directly stimulating the brain, it aims to train users to self-regulate brain activity for relaxation and focus.

Founded in 2007, by Ariel Garten, and a few other founders, Muse offers a variety of headbands catering to different needs, from general well-being to focus improvement. Muse headbands are manufactured by InteraXon, a company based in Toronto, Ontario, Canada. 

Flow Neuroscience Headset

Similar to Muse, Flow’s headset utilises neurofeedback to help users achieve calmness and focus. Founded in 2016 by Daniel Mansson and Erik Rehn, Flow offers a subscription-based service with personalised training programs tailored to individual goals.

Oura Ring 

This ring takes a more physiological approach, tracking sleep patterns, heart rate variability, and body temperature to provide insights into overall health and recovery. The company was founded in 2013 by Petteri Lahtela, Kari Kivelä, and Markku Koskela. Oura positions itself as a holistic wellness tracker, not solely targeting mental health.

Dreem Headband 

Dreem offered a headband that monitored brain waves and sleep patterns to personalise sleep sounds and optimise sleep quality. Founded in 2016, by Hugo Mercier, Dreem was acquired later by Boston-based Beacon in 2023, suggesting a potential shift in focus for the technology.

Key differentiators between these wearables

While all these companies aim to improve mental well-being, some key differentiators set them apart:


Neurovalens utilises electrical brain stimulation, while Muse and Flow rely on neurofeedback through EEG. Oura takes a more physiological approach with sleep tracking. Dreem, now under Beacon, presents a wait-and-see situation regarding its future direction.

Target audience

Neurovalens caters specifically to anxiety treatment, while Muse and Flow offer broader applications for relaxation and focus. Oura targets overall wellness, and Dreem’s future focus remains unclear.

Clinical validation

Neurovalens holds the distinction of FDA clearance for a medical device, indicating clinical validation for treating anxiety. The other companies might not have the same level of clinical backing for specific conditions.

Our thought about the startup and the wearable tech market

The mental health wearable market is dynamic and constantly evolving. As the science behind these devices progresses, we can expect even more sophisticated and targeted solutions. Here are some potential future developments:

Mental health wearables could become valuable tools for therapists, providing data-driven insights into a patient’s progress. Wearables may become more personalised, tailoring interventions and recommendations based on individual user data and preferences. We might see a rise in wearables targeting specific mental health conditions like depression or ADHD.

Neurovalens’ entry with FDA clearance is a significant step, but it’s important to recognize the ongoing development in the broader field of mental health wearables. Further research is needed to determine the long-term effectiveness of electronic brain stimulation compared to other technologies and to establish its place within a comprehensive treatment plan for anxiety and other mental health conditions.

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