DeepWell Digital Therapeutics (DTx) has secured FDA 510(k) clearance for its technology designed for use in immersive media, such as video games, focusing on stress reduction and as an adjunctive treatment for high blood pressure. This clearance allows DeepWell to offer its biofeedback software development kit (SDK) to video game developers and media companies for integration or adjacent use with their products.

The core technology was previously employed in DeepWell’s Zengence mental health action shooter game, which was launched earlier this year. The FDA clearance specifically covers the SDK, not the game itself. The approval applies to any media that maintains the safety and efficacy of the biofeedback mechanism, and is valid across mobile platforms and commercial channels.

DeepWell is collaborating with various media and medical device companies and will be announcing these partnerships in the near future. Out of 350,000 digital wellness apps worldwide, only 20 have received FDA clearance as digital therapeutics, with five focused on mental health, and DeepWell’s SDK is the only one allowing for further development in this domain.

The SDK facilitates biostimulation through interactive media by activating the vagus nerve, which reduces sympathetic nervous system activation, increases dopamine levels, and enhances resilience to stress and hypertension. Products using this SDK will be available over-the-counter on mobile platforms.

DeepWell is also working on new engagement mechanisms and therapeutic concepts that could address pain, PTSD, sleep disorders, immune system conditions, and neurological diseases such as epilepsy, Parkinson’s, and Alzheimer’s.

This development represents a notable advancement in neurology, with potential for significant impacts on the field of medicine. The introduction of Digital Mental Health Treatment (DMHT) device codes by the Centers for Medicaid and Medicare Services (CMS) starting in 2025 may support reimbursement for this technology, as advocated by the Digital Therapeutics Alliance (DTA) and supported by Congressional efforts. This advancement is expected to offer valuable mental and physical health support to many American families.




Source: deepwelldtx.com

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