DeepWell DTx wins FDA clearance of software development kit, with first indications for stress reduction and hypertension

DeepWell Digital Therapeutics (DTx) has won FDA 510(k) clearance of technology to be used in immersive media like video games for stress reduction and as an adjunctive treatment for high blood pressure.

The digital therapeutics developer plans to make its biofeedback software development kit (SDK) available to video game developers and media companies to embed or use adjacently with their products, DeepWell co-founder and Chair Ryan Douglas said in an interview ahead of the company’s official announcement.

DeepWell used the core technology for the Zengence mental health action shooter game it launched earlier this year.

“We cleared the software development kit. We did not clear the game,” Douglas said. “We cleared something that you can use to either put into a piece of media or adjacent to that media. The latitude that we were given [covers] any piece of media that doesn’t change the safety or efficacy of the core biofeedback mechanism — very broad — through any mobile platform … and through any commercial means.”

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