DeepWell DTx receives FDA clearance for its therapeutic video game developer tools

There’s something oddly refreshing about starting the day by solving the Wordle. According to DeepWell DTx, there’s a scientific explanation for why our brains might feel just a bit better after a quick break to play a game. In fact, DeepWell now has the FDA clearance to support its claim that video games can treat stress.

With FDA clearance, DeepWell’s biofeedback software development kit is approved for over-the-counter use, meaning that patients can use its games as a supplement to other treatments for stress or hypertension. As Medicare weighs the benefits of reimbursing doctors for digital therapy software, it’s possible that DeepWell’s games could become eligible for reimbursement.

FDA-approved medical devices don’t have to be developed solely for medical purposes. Apple’s AirPods Pro just got FDA approval to serve as hearing aids, making them the first over-the-counter hearing aid software device. Consumer products like the Garmin watch and certain Apple Watch apps have also been approved to monitor conditions like atrial fibrillation and Parkinson’s disease. As rates of anxiety and depression escalate in the U.S., it’s no wonder that medical regulators are looking for solutions from unconventional sources, like a gaming developer kit.

“What I believe you’re seeing happening at the moment is a recognition of the mental health emergency we’re under and the resource constraints that we’ve got,” co-founder Ryan Douglas told TechCrunch. “What we’ve done is we’ve cleared a toolkit that allows media creators to connect media to the reimbursement stream that’s coming now for digital mental health.”

For over 20 years, Douglas has been designing therapeutic hardware and software, earning more than 30 patents for treatment systems and medical devices. Now, he is the president and CEO of NeuFluent, a venture studio for neurological products, which DeepWell is part of.

DeepWell doesn’t recommend its products to be used instead of talk therapy, but rather, as a supplement.

“We’ve seen amazing results, sometimes as much as four times more effective than talk therapy or a drug,” he said. “But in combination with talk therapy, it has been out of this world.”

As a proof of concept, DeepWell put out a virtual reality game on Meta Quest called Zengence, which it calls a “mental health action shooter.” The headset can sense the player’s breath, and by maintaining a consistent breathing pattern, it becomes easier to defeat enemies.

Games don’t need to have such overtly therapeutic mechanics to be useful. According to Douglas, even games like Super Mario or Animal Crossing can have positive effects.

As with anything, video games should be enjoyed in moderation — for the sake of both your physical and mental health, you probably shouldn’t play Tears of the Kingdom for 12 hours a day. But, DeepWell argues that playing a game for 15 minutes, three times a week — the “dose” it was cleared for by the FDA — can have noticeable benefits.

“It turns out that this overlap between being in a playful state — in a heavily dopaminergic state — while you’re gaining a lot of agency and having a lot of positive interaction… You’re really bioavailable to learn new things about yourself,” he said.

Playing games that capture our attention can also offer a temporary respite from our negative thoughts and feelings.

“If you’re playing Tetris, for instance, you can’t have a big conversation in your head about how terrible you are, and how you suck, and what’s going to go on next week, and all that,” Douglas said.

Then, the limbic system — the part of the brain responsible for reacting to stress — could become susceptible to learning new ways of coping with negative stimuli. So as we get more practice coping with stressors — even fake ones from a video game — it can impact how we respond to real-life stress.

“We see a lot of folks with high levels of stress, that have been through wars and stuff like that, and they go back and they actually play games that give them jump scares and have thrills,” Douglas said. “There’s a desire to get in and have control over an environment that they didn’t have control over before.”

So far, DeepWell is cleared to treat stress and hypertension, but Douglas hopes that in the future, this technology could treat PTSD, epilepsy, sleep disorders, and memory disorders. Though DeepWell’s work focuses on digital media, Douglas thinks that these same principles can be observed through other forms of entertainment.

“That’s why you see people go into a concert or a movie, and they come back out two hours later thinking differently about what they’re going to do next,” he said. “In that time, you’ve overcome a major hurdle, or got over a rut in your thinking that you otherwise couldn’t do without that stimulus.”