Benzinga | Sep 22, 2020 08:06AM EDT

NanoVibronix UroShield Receives FDA Authorization For Entry Into US

ELMSFORD, N.Y., Sept. 22, 2020 /PRNewswire/ -- NanoVibronix, Inc.,(NASDAQ:NAOV), a medical device company that produces the UroShield(r), PainShield(r) and WoundShield(r) Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that the U.S. Food and Drug Administration ("FDA") has decided to exercise its Enforcement Discretion to allow distribution of the UroShield device in the United States. According to the FDA, "UroShield(r) device can use Intended Use Code (IUC) 081.006: Enforcement discretion per final guidance, and FDA product code QMK (extracorporeal acoustic wave generating accessory to urological indwelling catheter for use during the COVID-19 pandemic)".