"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."
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 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.
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.
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