FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults

FDA

6 November 2020 - Today, the U.S. FDA permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder. 

The device provides gentle vibration through touch based on an analysis of heart rate and motion during sleep.

The device, called Nightware, is a digital therapeutic that uses an Apple Watch and an Apple iPhone that are configured and logged into a software application and the Nightware server.

Read FDA press release

Michael Wonder

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Michael Wonder

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Outcome , US , Device