If there are lingering doubts about the viability or market potential of digital therapeutics (DTx), recent moves by the U.S. Food & Drug Administration should lay them to rest. In December 2018, Pear Therapeutics and its partner, Novartis’ Sandoz unit, received FDA clearance for reSET-O, a prescription-only mobile medical app that helps patients with opioid use disorder remain in outpatient treatment programs. The same month, with support from regulators, the ECG app on the Apple Watch 4 became the first direct-to-consumer product that can notify users of an irregular heart rhythm.


While these two examples stand out, there are dozens of other software-driven products under regulatory review for diagnosing, treating, or preventing medical conditions. As Sandoz CEO Richard Francis said in a press release announcing the reSET-O, digital therapeutics “have the potential to fundamentally change how patients interact with their therapies,” and may represent “the next chapter of medical innovation.”


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