NanoVibronix Receives FDA 510(k) Premarket Clearance for PainShield Plus

Tuesday, November 29, 2022

NanoVibronix, Inc., a medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave (SAW) technology, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its PainShield® MD PLUS, its dual-actuator ultrasound pain therapy device.

Brian Murphy, CEO of NanoVibronix, stated, “Securing 510(k) clearance for PainShield Plus is a key milestone towards achieving permanent clearance from the FDA and full-scale commercial marketability. Increasingly, healthcare providers and patients are seeking effective, non-pharmaceutical therapies for the treatment of chronic pain. PainShield Plus expands on the effectiveness of its predecessor, our original PainShield M.D., by covering twice the treatment area and broadening the opportunities for application. As a result, we have started the process of making the recommended modifications to the device in order to comply with the FDA standard. In addition, this approval opens the door for us to submit a 510(k) application for our Over-The-Counter product, PainShield Relief, in the near term.”

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