DeepWell DTx, a company known for blending gaming with health tech, has received FDA clearance for its innovative biofeedback software development kit (SDK), which integrates therapeutic features into video games. This groundbreaking approval allows games developed using DeepWell’s tools to help reduce stress and manage conditions like hypertension — all without the need for a prescription.

The FDA’s green light means DeepWell’s SDK can now be used in over-the-counter treatments, marking a significant shift in how video games are perceived in the health and wellness space. DeepWell’s technology uses biofeedback to help players manage stress, making gaming a potential tool for mental health therapy.

The SDK has been integrated into DeepWell’s own mental health game, Zengence, which is available on Meta’s Quest VR platform. In this game, players use controlled breathing to reduce stress and enhance their performance. This blend of biofeedback and gameplay helps activate the vagus nerve, a key player in relaxation, promoting both immediate and long-term mental health benefits.

DeepWell’s co-founder, Ryan Douglas, sees this approval as a major step forward in addressing mental health challenges. The company’s games are designed to complement existing treatments, not replace them. Douglas explains that combining therapeutic games with traditional talk therapy can offer remarkable results, sometimes even outperforming standalone therapies.

With the FDA’s approval, DeepWell now aims to expand its technology to treat conditions like PTSD, epilepsy, and sleep disorders. The company is also hopeful that upcoming Medicare and Medicaid reimbursement codes will enable doctors to prescribe digital therapies, making therapeutic games more accessible to millions of people.

This FDA approval is a game-changer, positioning DeepWell at the intersection of healthcare and entertainment and proving that video games can indeed be used for more than just fun — they can also help heal.

Sara Sheehan

Sara Sheehan

Sara Sheehan is a talented software engineer with a passion for exploring various tech topics. She has a strong expertise in web development, software development, and digital marketing, continually expanding her knowledge in these areas. Sara is dedicated to staying ahead of the curve in the ever-evolving tech industry, always seeking out new challenges and opportunities to grow her skill set.