FDA fast-tracks Apple Watch app for those with PTSD nightmares

NightWare, a smartwatch app that uses artificial intelligence to measure and treat nightmares in users with post-traumatic stress disorder, has received "Breakthrough Status" from the FDA.

The app runs on the Apple Watch platform and collects biometric data while a user sleeps. Its machine learning algorithms use the data to create a sleep pattern profile, which allows the app to detect the onset of nightmares and use vibrotactile feedback to interrupt the nightmare without fully waking the user or interrupting their circadian sleep rhythm.

The "Breakthrough Status" designation, reserved for therapies for life-threatening conditions with no approved treatments, will expedite NightWare's ongoing randomized clinical trials, then grant the app priority review for FDA approval.

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