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 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 […]
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 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.