DeepWell Digital Therapeutics DTx has received FDA clearance for its biofeedback software development kit, SDK, advancing the use of video games and interactive media to address mental health challenges.

The SDK is approved for over-the-counter treatments to reduce stress and can also serve as a complementary therapy for managing high blood pressure. DeepWell’s chairman and co-founder, Ryan Douglas, shares that the company was created to tackle mental health issues like anxiety, depression, and loneliness, which become more prevalent during the pandemic.

The FDA approval process took about three and a half years, much quicker than the eight-to-ten-year timeline for new drug approvals. Now, with FDA clearance, DeepWell can commercialize its SDK, making it available to media and game developers to integrate therapeutic features into their products. These tools are accessible without a prescription, making therapeutic games more widely available to the public.

The SDK integrates directly into select media products, enabling seamless therapeutic interactions within entertainment experiences. For example, breathing mechanics that reduce stress can be embedded into gameplay, where players’ actions, like controlling their breathing, enhance performance or trigger therapeutic outcomes. This integration accelerates the adoption of immersive media as FDA-cleared digital therapeutics.

DeepWell’s technology, first showcased in the mental health game Zengence:Take Aim with Every Breath. In Zengence, players use audible breathing—humming, chanting, or singing—to control an Orb in the VR world. The combination of breath control, motion, precision, and rhythm helps regulate emotions, release endorphins, and provide a positive distraction from negative thoughts. Zengence:Take Aim with Every Breath is available on the Meta Game Store and is compatible with Meta Quest 2 and 3 VR headsets.

Douglas emphasizes the therapeutic potential of well-designed games, stating that the SDK uses biofeedback to activate the vagus nerve, enhancing relaxation and stress reduction while increasing user engagement. This results in games that not only entertain but also provide immediate and long-term health benefits, such as reduced stress and hypertension. The technology places players in a state of “flow,” a deeply immersive mental state that promotes focus and relaxation.

Recent proposals from the Centers for Medicaid and Medicare Services may further revolutionize digital therapeutics. New reimbursement codes may enable digital mental health treatments to be covered by insurance, encouraging companies to develop therapeutic games, doctors to prescribe them, and patients to use them. This could significantly expand access to mental health treatments through video games and other media.

Beyond stress and hypertension, DeepWell explores applications of its technology for conditions like PTSD, epilepsy, and sleep disorders. Although these applications are not yet FDA-approved, DeepWell is conducting research to assess their viability. The company holds several patents and is collaborating with major media and medical companies on potential projects.

FDA clearance for DeepWell paves the way for integrating mental health treatments into popular video games and immersive media. With potential insurance reimbursement, these therapeutic games could reach millions, creating new opportunities for video games to serve both entertainment and healthcare needs.