FDA clears DeepWell SDK to be used in games for stress reduction

Mental health-focused studio DeepWell has received clearance from the US' Food and Drug Administration for its biofeedback SDK to be used therapeutically to help with stress reduction and high blood pressure.

This means DeepWell will be able to make the SDK available to other firms who might want to use it, with the end goal to "accelerate the commercialisation of video games and other immersive media as FDA-cleared digital therapeutics," the announcement said.

It clarified that any media incorporating DeepWell technology will be available without needing a prescription.

DeepWell's SDK is described as providing "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."

When asked for more details and clarification about what it means and about the practical applications, a spokesperson for the company told GamesIndustry.biz that the SDK can be implemented primarily in three ways, and took the integration of a breathing mechanic as an example (DeepWell previously released a VR game called Zengeance where players had to breathe audibly as part of the main gameplay mechanic).

One option is to have said breathing mechanic be incorporated directly as part of a title's gameplay, with the spokesperson explaining: "For example, in a sports game players could hold a vocal hum to accurately fill a metre to get the perfect swing. Or the player could enter a 'sharpshooter' game where they must relax and control their breathing to eliminate camera movement and increase their accuracy."

The second option is to have it be "adjacent to the media," the firm said, explaining: "For example, in a Zelda game you could enter a special temple that enhances your player abilities for completing a breathing challenge."

Finally, the breathing mechanic can be "added to a platform of organised content," with the example given being a distinct 'Mental health' tab on Netflix or the App Store that "shows specifically recommended games/apps/shows/movies for mental health, with a recommendation to try a game or media that has the breathing mechanic enabled."

It's unclear exactly how that differs from existing mental health-focused apps that offer breathing exercises, or what other applications are possible.

Co-founder of DeepWell and paediatric neurosurgeon Dr. Samuel Browd explained as part of the announcement that only 20 out of 350,000 digital wellness products have been FDA cleared, "including just five for mental health and only one SDK" (which is DeepWell's).

Co-founder and chairman Ryan Douglas further explained: "Our technology could be used in future digital treatments for pain, PTSD, epilepsy, sleep disorders, immune disorders, Parkinsons, Alzheimer's, and as a critical connection point for brain computer interfacing."

DeepWell was founded in March 2022, originally the brainchild of Douglas and of Devolver Digital co-founder Mike Wilson. The latter announced last May that he departed the firm in late 2023 "along with almost all of the games industry colleagues [he] brought to that company."

He explained: "[I] have absolutely nothing to do with the game they released on the Quest store (which they called Zengeance) and which my colleagues also asked to have their names removed from. I still have high hopes and strong beliefs for the power of games and other digital media to benefit people, but could not see a path to getting it done in that company."