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BioWorld - Wednesday, May 31, 2023
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Home » FDA gives green light for therapeutic to reduce sleep disturbance related to nightmares
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FDA gives green light for therapeutic to reduce sleep disturbance related to nightmares

Nov. 9, 2020
By Liz Hollis
No Comments
The U.S. FDA has given its nod to a new solution that aims to help with the temporary reduction of sleep disturbance related to nightmares in certain people. Specifically, the agency reviewed the device, from Minneapolis-based Nightware Inc., through the de novo premarket review pathway and now is permitting its use in patients aged 22 years of age or older who are suffering from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The agency previously granted the solution breakthrough device designation.
BioWorld MedTech Regulatory Neurology/Psychiatric Artificial intelligence Digital health Wearable De novo FDA

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