DeepWell Gains FDA Clearance for Immersive Media for Mental Health Care

DeepWell Digital Therapeutics (DTx), which commercializes immersive medical media for mental and physical health, has received 510(k) clearance from the FDA for its biofeedback (ABS) software development kit (SDK) for use in over-the-counter treatments for the reduction of stress and as an adjunctive treatment for high blood pressure, together with other pharmacological and/or nonpharmacological interventions. 
 
DeepWell will make the new technology available to media companies to embed or use adjacently with their products, which allows the potential to accelerate the commercialization of video games and other immersive media as FDA-cleared digital therapeutics. 
 
“The mental health emergency has reached unprecedented levels, profoundly impacting us all. That’s why DeepWell has been working to create accessible, affordable health care solutions at scale. With the work the Digital Therapeutics Alliance (DTA) has done to secure reimbursement pathways, the last mile was to build technology that allows engaging media to be efficiently evaluated and marketed as a medical device. That is what our team has accomplished,” said Ryan Douglas, DeepWell Co-Founder and Chairman.
 
Clearance for this device by the FDA is significant given the recent (July 2024) proposal from the Centers for Medicaid and Medicare Services (CMS) for codes that would enable Digital Mental Health Treatment (DMHT) devices to become reimbursable as a physician service in 2025. These codes would provide monetary incentives for companies to develop, doctors to recommend, and patients to use DTx that incorporates DeepWell technology.
 
DeepWell’s software provides biostimulation in interactive media that activates the user’s vagus nerve while greatly increasing patient engagement, reducing sympathetic nervous system activation, and releasing dopamine for coping that improves resilience to reduce stress and hypertension. Immersive biofeedback-driven media increases consistent use for immediate and long-term mental and physical health benefits.
 
“This is a significant neurological advancement with the potential to take medicine to the next level,” said Dr. Samuel Browd, co-founder of DeepWell DTx, leading pediatric neurosurgeon at the University of Washington, and advocate for Artificial Intelligence and Computational Brain Sciences for the American Association of Neurological Surgeons and Congress of Neurological Surgeons. “Makers of interactive media – used by five billion people — can now leverage DeepWell’s technology toward creating new therapeutic solutions.” Browd notes that there are more than 350,000 digital wellness products, of which 90,000 have been piloted during the FDA Covid emergency order, yet only 20 have been FDA cleared, including just five for mental health and only one SDK, from DeepWell DTx. 
 
“DeepWell has opened a significant new revenue stream for media and entertainment by creating the reimbursable immersive medicine market,” said Lauren Selig, executive producer and investor in academy award winning films and video games, including Hacksaw Ridge, Rocketman, Wheel of Time, Build a Rocket Boy, and FOAD. “This is a moonshot opportunity blending powerful media into digital therapeutics that effectively target the global mental health crisis.”
 
The company has been prototyping and conducting viability assessments on the use of its technology with some of the largest media and medical device companies in the world. It expects to begin announcing its first collaborations soon. 
 
“Working with DeepWell, companies can now significantly reduce the time and cost of bringing their mental and physical health solutions to market,” said Jeffrey Tseng, DeepWell DTx CEO. DeepWell has a dedicated following of individuals who have reported relief and improved mental wellbeing using the technology. The company is also piloting new engagement mechanics and therapeutics concepts.
 
Tseng said the FDA clearance has spurred additional interest in the company from partners and investors and its technology has been reviewed and endorsed by dozens of innovators in digital therapeutics, media, medicine, and mobile, including Dr. Russell Lonser, chair of the Department of Neurological Surgery at The Ohio State University, one of the world’s preeminent authorities on the nervous system.
 
“Our technology could be used in future digital treatments for pain, PTSD, epilepsy, sleep disorders, immune disorders, Parkinsons, Alzheimer’s, and as a critical connection point for brain computer interfacing,” said Douglas.
 
Those additional indications are not yet cleared, but the company may pursue them.
 
Media featuring DeepWell technology can be available to consumers over the counter (without a prescription) on all mobile device platforms.