"A Breakthrough Device"
-US FDA
In 2020, the FDA designated NightWare a Breakthrough Device. It's the agency's way to acknowledge new treatments are needed for a condition that is life threatening or irreversibly debilitating where an unmet need has been identified and preliminary data suggest a clinical benefit. It also allows the FDA to expedite the development and review of these devices.
A distinctive category of medicine
NightWare is an example of medical innovation known as a prescription digital therapeutic. Here’s what that means:
PRESCRIPTION
Only available when a clinician writes a prescription for use by a patient. It’s a medical-grade platform and you can’t get it from the App Store® or Google Play.
DIGITAL
Rather than a mechanical or electrical device, or a chemical or biological compound, the product uses an electronic hardware/software platform.
THERAPEUTIC
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.
Google Play and the Google Play logo are trademarks of Google LLC.
HOW IT WORKS
Using artificial intelligence and other cutting-edge, smart technology, NightWare continually evaluates a user’s stress index (level of sleep disturbance) during sleep by tracking the heart rate and body movements.13 NightWare uses the Apple Watch® heart monitor sensor and other biometric sensors to determine when someone is having a nightmare. This highly detailed information is monitored in real time. When a nightmare is detected, the system rapidly delivers short vibrations to interrupt nightmares without waking the patient. NightWare’s first-of-its-kind technology platform customizes the intensity and frequency of the vibrations based on the person’s specific needs at that moment.
FOUR STEPS TO BETTER SLEEP
Patients and health care professionals appreciate that NightWare is easy to use.
Clinical trial data demonstrate that NightWare is effective in improving sleep within two weeks.
Health care professionals: Click here to view and download the Instructions for Use.
The more you use it, the smarter it gets.
Increased use generates better learnings. NightWare is constantly capturing data and adapting to the patient’s evolving sleep patterns. Our prescription digital therapeutic platform creates a customized intervention based on the ongoing accumulation of data from the user. The more you use NightWare, the smarter it gets.
PROVIDER INSTRUCTIONS
Read NightWare’s Instructions for Use, written specifically for health care professionals.
PROVIDER IFU
PATIENT INSTRUCTIONS
Read NightWare’s Instructions for Use, written specifically for patients and caregivers.
PATIENT IFU
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