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The agency has cleared the first digital wellness software development kit. Excerpted from Pathways’ Picks September 11: Harmonization Progress, Brazil Regulation, and Novel Software Sign-Off.
DeepWell DTx announced a 510(k) clearance this week for a software tool that video game and other immersive media developers can embed in their products and sell over-the-counter to treat stress and aid in lowering users’ blood pressure. The Seattle-based firm, which already sells a mental health action shooter game (Zengeance) that employs breath monitoring and biofeedback technology, says its product is the first “digital wellness” software development kit to be cleared by FDA. FDA’s summary of the clearance, granted last month, explains the software can be used for relaxation and as an adjunctive treatment for hypertension on Android operating systems, employing microphones or accelerometers that are standard on mobile devices for breath monitoring. Products utilizing the software will be able to leverage anticipated new reimbursement codes for Medicare payment of physician-prescribed mental health software, DeepWell says. “Working with DeepWell, companies can now significantly reduce the time and cost of bringing their mental and physical health solutions to market,” said company CEO Jeffrey Tseng, who noted the firm has been working with media and medical device companies in advance of the clearance.