The FDA has granted clearance for the DeepWell SDK, allowing its integration into video games designed to alleviate stress.
DeepWell, a studio focusing on mental health, has received approval from the U.S. Food and Drug Administration (FDA) for its biofeedback software development kit (SDK). This tool is designed for therapeutic applications, specifically to assist in managing stress and high blood pressure.
With this approval, DeepWell can now distribute the SDK to other companies, aiming to "accelerate the commercialization of video games and other immersive media as FDA-cleared digital therapeutics," as mentioned in their announcement. Notably, no prescriptions will be required for media utilizing DeepWell's technology.
The SDK is characterized by its ability to provide "biostimulation in interactive media," which targets the user's vagus nerve. This process enhances patient engagement, diminishes sympathetic nervous system activation, and releases dopamine, aiding users in building resilience to tackle stress and hypertension.
A DeepWell representative, speaking to GamesIndustry.biz, outlined that the SDK can be integrated through three main approaches. For instance, they demonstrated a breathing technique through a previous VR game called Zengeance, where players utilized audible breathing as a core gameplay element.
One potential integration is embedding the breathing mechanic directly into a game's gameplay. For example, in a sports game, players might use a vocal hum to precisely fill a meter, achieving the perfect swing. Alternatively, in a 'sharpshooter' scenario, players would need to relax and control their breathing to minimize camera movement and improve aiming precision.
The second integration method involves embedding the mechanic alongside the media. For example, a special temple in a Zelda game could boost player abilities after completing a breathing challenge.
The third application involves adding the feature to a curated content platform. An example is the creation of a distinct 'Mental health' section on platforms like Netflix or the App Store, presenting specially recommended games/apps/shows/movies for mental health enhancement, particularly those using the breathing mechanic.
Despite its promise, the specific distinctions from current mental health apps offering breathing exercises remain unclear, as well as other potential uses.
Dr. Samuel Browd, DeepWell's co-founder and a pediatric neurosurgeon, highlighted that only 20 out of 350,000 digital wellness products have received FDA clearance, with just five focusing on mental health and only one SDK, theirs.
Ryan Douglas, co-founder and chairman, added that their technology holds future potential for digital treatments addressing conditions such as pain, PTSD, epilepsy, sleep disorders, immune disorders, Parkinson’s, Alzheimer’s, and could be a vital link for brain-computer interfacing.
DeepWell was established in March 2022, spearheaded by Douglas and Mike Wilson, the latter being a co-founder of Devolver Digital. Wilson announced his departure from the company in late 2023, as did nearly all his gaming industry colleagues, expressing discontent with the company's direction. He clarified that he had no involvement in the release of the game Zengeance on the Quest store and the request to have his and his colleagues' names removed from it.
