South African medtech developer Xavant Technology said today it won FDA clearance for its Stimpod NMS460 non-invasive neuromodulation device designed for treating chronic intractable pain.
The company said the device is designed for treating chronic pain as well as an adjunctive treatment for managing post-surgical pain, post-traumatic acute pain problems and as an adjunct for pain control due to rehabilitation.
The Stimpod is designed to apply a hybrid pulsed radio frequency waveform to an affected area transcutaneously, which the company claims creates electromagnetic effects similar to pulsed radio frequency treatments, which have been shown to relieve chronic intractable pain.
The system includes a nerve-locating technology featuring a nerve mapping probe to allow practitioners to locate and evaluate treatment progress, Xavant said.
“We are thrilled at the news that our revolutionary device can now be used in the US. This groundbreaking technology has the ability to help tens if not hundreds of millions of people just in the U.S. as a valuable treatment asset for neurologists, chiropractors, acupuncturists, physical therapists, physiatrists, and medical pain practitioners,” CEO Corlius Birkill said in a prepared statement.
Xavant Technology said it has chosen Bell Medical to act as its distributor in both the US and Canada.