Sam Brusco, Associate Editor11.29.22
NanoVibronix, a company using its proprietary and patented low-intensity surface acoustic wave (SAW) tech, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its PainShield MD PLUS dual-actuator ultrasound pain therapy device.
Brian Murphy, CEO of NanoVibronix, told the press, “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.”
PainShield Plus uses ultrasound therapy to treat pain and various soft tissue injuries either directly over joints or orthopedic hardware without ultrasound gels.
It consists of a reusable driver unit and disposables, including a proprietary therapeutic transducer and cover adhesive. Its applications include acute and chronic pain resolution at home, work, or in a clinical setting. It can even be used as the patient is sleeping.
Brian Murphy, CEO of NanoVibronix, told the press, “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.”
PainShield Plus uses ultrasound therapy to treat pain and various soft tissue injuries either directly over joints or orthopedic hardware without ultrasound gels.
It consists of a reusable driver unit and disposables, including a proprietary therapeutic transducer and cover adhesive. Its applications include acute and chronic pain resolution at home, work, or in a clinical setting. It can even be used as the patient is sleeping.