Immersive medical media company DeepWell Digital Therapeutics (DTx) has received 510(k) clearance from the Food and Drug Administration (FDA) on its biofeedback (ABS) software development kit that can be used for pain, PTSD, epilepsy, sleep disorders, immune disorders, Parkinsons, and Alzheimer’s.
The clearance will allow the DeepWell kit to be used in over-the-counter treatments for the reduction of stress and as an adjunctive treatment for high blood pressure, together with other pharmacological and 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 commercialisation of video games and other immersive media as FDA-cleared digital therapeutics.
Media featuring DeepWell technology can be available to consumers over the counter without a prescription on all mobile device platforms.
“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.
The DeepWell 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.
“The DeepWell clearance, along with DTA’s work with Congress to secure reimbursement pathways, will bring mental and physical health support to millions of struggling American families,” added Andy Molnar, CEO at Digital Therapeutics Alliance and member of the FDA Digital Health Advisory Committee.
“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.”
“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.”
“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.
The company has confirmed it is also piloting new engagement mechanics and therapeutics concepts.
“Our technology could be used in future digital treatments for pain, PTSD, epilepsy, sleep disorders, immune disorders, Parkinson’s, Alzheimer’s, and as a critical connection point for brain computer interfacing,” said Douglas, noting those additional indications are not yet cleared but the company may pursue them.
DeepWell 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. 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. “I expect DeepWell’s technology and treatment approach to change how we design therapeutics for a wide range of neurological conditions.”
