Stimwave Technologies said late last week it won approval from the Australian Therapeutic Goods Administration for its Freedom spinal cord stimulation system, and launched the device in the country. The Ft. Lauderdale-based company touts the Freedom SCS as the world’s 1st wireless, fully programmable neuromodulation device intended for treating chronic, intractable pain of the back or […]
Stimwave
StimRelieve launches craniofacial chronic pain trial
Stimwave Technologies spinout StimRelieve said today it enrolled the 1st patient in a clincal trial of its implantable StimRelieve device designed to treat chronic craniofacial nerve pain. The Ft. Lauderdale, Fla.-based company’s device is designed to be implanted near inflicted painful nerves to modulate nerve activity and provide therapeutic relief, the company said. The device is powered […]
FDA clears Stimwave’s StimQ wireless chronic pain stimulator
Stimwave Technologies said today that it’s putting its StimQ peripheral nerve stimulator on the U.S. market after winning pre-market approval from the FDA earlier this month. The StimQ device is designed to treat severe, intractable chronic pain in peripheral nerves, according to Ft. Lauderdale-based-based Stimwave. The tiny device, which is less than 5% of the size […]
Stimwave wins FDA 510(k) for SCS device
Stimwave Technologies said it won FDA 510(k) clearance for its Stimwave Freedom-8A 8-electrode wireless neuromodulation spinal cord stimulation device for relieving chronic back and leg pain. The Fort Lauderdale, Fla.-based company said it is the 1st wireless, fully programmable SCS neuromodulation device available. Stimwave said it has begun commercialization of the device and began implantation […]
Stimwave wins nod from FDA for IDE trial
Stimwave Technologies said yesterday it won FDA investigational device exemption clearance to test an 8-electrode version of its wireless miniature neurostimulator device for the relief of chronic back and leg pain. Miami, Fl.-based Stimwave said the FDA also approved a study of the device using high frequency treatments through an external pulse generator. “This study […]
FDA OKs trial for StimGuard’s bladder implant
StimGuard said it won an investigational device exemption from the FDA for a clinical trial of its micro-size implantable device to treat overactive bladder syndrome. StimGuard said its system uses a small injectable microchip and an external transmitter and requires no invasive surgery to implant. The trial is slated to begin in summer 2015.
Stimwave Technologies launches new chronic pain trial for mini neurostim device
Stimwave Technologies said it’s launching a new clinical trial for its miniature, wireless neuromodulation anti-pain device for treating chronic, non-specific-origin lower back pain.