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DeepWell DTx announces FDA clearance that draws on video games and other interactive media to treat | |
which commercializes immersive medical media for mental and physical health, today announced it has received 510(k) clearance from the Food and Drug Administration (FDA) on 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. Media featuring DeepWell technology can be available to consumers over the counter (without a prescription) on all mobile device platforms. 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 which would enable Digital Mental Health Treatment (DMHT) devices to become reimbursable as a physician service beginning in 2025. These codes would provide monetary incentives for companies to develop, doctors to recommend, and patients to use DTx that incorporates DeepWell technology. For more details please visit our website - https://www.medhealthreview.com/2025/06/17/deepwell-dtx-announces-fda-clearance-that-draws-on-video-games-and-other-interactive-media-to-treat-mental-health/  | |
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| Target State: New York Target City : New York City Last Update : Nov 11, 2025 4:45 AM Number of Views: 3 | Item Owner : medhealthreview Contact Email: (None) Contact Phone: (None) |
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2025-11-11 (1.094 sec)