FDA issues emergency clearance for NanVibronix device
By HME News Staff
Updated 9:21 AM CDT, Wed May 12, 2021
ELMSFORD, N.Y. - NanoVibronix, a medical device company that produces the UroShield, PainShield and WoundShield Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, has announced the U.S. Food and Drug Administration will exercise its enforcement discretion to allow distribution of the UroShield device in the United States during the current public health emergency. The device is designed to aid in the prevention of CAUTI incidence in patients requiring long-term indwelling catheterization. "The FDA continues its critical work to protect public health, including expediting the review of medical devices that may be of beneficial use during the COVID-19 pandemic," said Brian Murphy, CEO of NanoVibronix. "After reviewing the body of scientific evidence that we presented, the agency took decisive action to clear the way for patient access to UroShield for the duration of the COVID-19 pandemic.”
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