Apple Watch prescription sleep app from NightWare earns FDA approval - Business Insider

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The FDA's nod to Apple Watch's sleep app underscores the agency's digital health-friendly stance—especially in fast-tracking development of mental health tools amid the pandemic

Given that the pandemic is the mental health crisis, we don't expect the FDA to revert back to its stricter policies anytime soon—meaning more DTx startups will be able to commercialize their products quickly.

Several barriers to DTx uptake remain, including a lack of Medicare coverage—but we think the CMS may be inching closer to paying for these platforms, prying open a largely untapped potential pool of customers for DTx developers. Payers are a major distribution outlet for DTx firms—a payer tie-up gives DTx firms access to large member bases, and makes consumers more likely to use their tools since they don't have to pay out-of-pocket.

If approved, we expect this new MCIT pathway will allow DTx developers that've achieved de novo or breakthrough device designation—like NightWare—to earn coverage under Medicare and help reach the massive, largely untapped consumer base of Want to read more stories like this one? Here's how you can gain access:

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