FDA grants clearance for NightWare app designed to reduce PTSD-related nightmares

FDA grants De Novo clearance to prescription Apple Watch app for nightmare disorder (MobiHealth News): The FDA granted Minneapolis-based NightWare a De Novo clearance on Friday for its Apple Watch and iPhone app designed to improve the sleep quality of those experiencing nightmare disorder and nightmares related to PTSD. The digital therapeutic – which received breakthrough designation from the agency last year – uses the Watch’s sensors to track the heart rate and movement of users as they sleep. After establishing a baseline profile for the patient within one or two nights’ sleep, the machine learning algorithm spots heart rate or movement abnormalities presumably caused by a nightmare. The application then vibrates the smartwatch just enough to interrupt the wearer’s dreaming, but not enough to wake them up or disrupt their circadian sleep cycle. The digital therapeutic is intended for home use among adults aged 22 years or older and will require a prescription. The agency stressed in the announcement that it is not a standalone therapy for PTSD and should be used alongside other prescribed medications or recommended therapies. The FDA Announcement: FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults (press release): Today, the U.S. Food and Drug Administration permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older ...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health Technology & Innovation Apple Watch De Novo clearance digital therapeutic FDA heart-rate iPhone app machine-learning nightmares NightWare prescription PTSD sleep quality Source Type: blogs