FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults
The Pharma Data
NOVEMBER 6, 2020
director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. This device was studied in a 30-day randomized, sham-controlled trial of 70 patients. Patients in the sham group wore the device, but no vibratory stimulation was provided.
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