NightWare Kit

NightWare, Inc.

NightWare Kit

The FDA designated NightWare a Breakthrough Device

FDA Breakthrough Device Designation

Do you know anyone using NightWare Kit?

NightWare is a prescription digital therapeutic device that has been designated as a Breakthrough Device by the FDA in 2020. This designation is given to new treatments that address life-threatening or debilitating conditions where an unmet need has been identified and preliminary data suggests a clinical benefit. The device uses an electronic hardware/software platform and is only available with a prescription from a clinician. It utilizes artificial intelligence and other cutting-edge technology to continually evaluate a user’s stress index during sleep by tracking heart rate and body movements. When a nightmare is detected, the device delivers short vibrations to interrupt the nightmare without waking the patient. The intensity and frequency of the vibrations are customized based on the person’s specific needs at that moment. The device is designed to improve or have a favorable impact on a specific disease or condition with effectiveness and a safety profile cleared by the U.S. Food & Drug Administration.

NightWare Kit

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