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# FDA Authorizes NightWare Platform Marketing
- URL: https://www.fdaweb.com/fda-authorizes-nightware-platform-marketing/
- Published: 2020-11-11T12:00:00.000Z
- Updated: 2026-09-14T16:35:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148067

NightWare says FDA has given marketing permission through the *de novo* pathway for the company’s NightWare therapeutic platform that is the only medical device to be indicated for the temporary reduction of sleep disturbances related to nightmares in adults age 22 and older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). A company [statement](https://www.marketwatch.com/press-release/nightware-receives-fda-marketing-permission-for-first-and-only-medical-device-to-reduce-sleep-disturbances-related-to-ptsd-associated-nightmares-in-adults-2020-11-10?tesla=y&ref=fdaweb.com) says the NightWare platform uses artificial intelligence software installed on an Apple Watch that monitors the biometric pattern of an individual’s sleep cycle to identify elevated heart rate and body movement associated with nightmares and is then able to interrupt the nightmare by arousing the patient via gentle vibration.

FDA [says](https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-new-device-designed-reduce-sleep-disturbance-related-nightmares-certain-adults?ref=fdaweb.com) the device was studied in a 30-day randomized, sham-controlled trial of 70 patients. NightWare is not a standalone therapy for PTSD, the agency says, and should be used in conjunction with prescribed medications for PTSD and other recommended therapies for PTSD-associated nightmares and nightmare disorder.

The device was granted FDA breakthrough device designation. Along with the marketing authorization, FDA says it is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the agency says, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type.