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[author: Daniel Meckley]
Today’s wearable devices the ones that monitor the number of steps we take, our heart rate, and our sleep habits (to mention only a few) walk the line between personal accessories and true medical devices. To clarify the differences the FDA has issued several guidance documents including “General Wellness: Policy for Low Risk Devices” and “Policy for Device Software Functions and Mobile Medical Applications.”
Just recently, the FDA granted permission to market Nightware, a new device intended to treat sleep disturbance related to nightmares in adults with post-traumatic stress disorder or other nightmare disorders.
Nightware is a digital therapeutic device that uses an Apple Watch and an iPhone configured and logged into a software application along with the Nightware server. The Apple Watch sensors monitor body movement and heart rate during sleep, and these data are sent to the Nightware server which use a proprietary algorithm to create a