Medtronic announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system. The medtech giant designed OsteoCool 2.0 to treat painful bone metastases and benign bone tumors like osteoid osteoma. The minimally invasive procedure uses probes to deliver radiofrequency energy that heats and destroys tumors. Meanwhile, it circulates water to […]
Pain Management
Mainstay Medical raises $125M for neurostim tech
Mainstay Medical announced an equity financing worth $125 million set to support the commercial growth of its neurostimulation technology. The company plans to put its new funds toward commercializing its ReActiv8 system in the U.S., Europe and Australia. It also has eyes on using the money for post-market clinical studies and research, plus general operations. […]
ShiraTronics completes implantable migraine therapy pilot enrollment, sets up U.S. clinical study
ShiraTronics announced that it completed enrollment in a pilot study of its minimally invasive implantable migraine therapy. Minneapolis-based ShiraTronics designed its neuromodulation system to address the debilitating symptoms of migraines. The company says it offers the first-ever fully implantable system for head location utilizing a minimally invasive approach. The fully implantable, programmable device delivers precise […]
FDA expands approval for Boston Scientific spinal cord stim to include chronic back pain without prior back surgery
Boston Scientific announced today that the FDA approved an expanded indication for its WaveWriter spinal cord stimulation (SCS) systems. The indication covers chronic low back and leg pain in people without prior back surgery — called non-surgical back pain (NSBP). Boston Scientific says first-line treatment for people with chronic back pain tends to have limitations. […]
Boston Scientific has positive spinal cord stimulation data
Boston Scientific announced positive one-year results from a trial evaluating its spinal cord stimulation (SCS) technology. The SOLIS randomized control trial demonstrated sustained pain relief with the WaveWriter Alpha SCS system for treating non-surgical back pain (NSBP). Boston Scientific presented data at the 2024 North American Neuromodulation Society (NANS) meeting in Las Vegas. Dr. James […]
Medtronic has positive spinal cord stimulation data
Medtronic today announced data from two clinical trials supporting its spinal cord stimulation (SCS) technologies. The medtech giant shared data at the North American Neuromodulation Society (NANS) annual meeting in Las Vegas. Results demonstrated the benefits of SCS in patients with chronic low back pain (CLBP) and leg pain. The company also plans to highlight […]
FDA approves expanded MRI labeling for Abbott Proclaim neurostim
Abbott announced today that the FDA approved expanded MRI labeling for its Proclaim DRG neurostimulation system. Proclaim DRG provides targeted relief for people with complex regional pain syndrome (CRPS) types I and II of the lower limbs. It stimulates the dorsal root ganglion (DRG) clusters of nerve cells found along the spine. Abbott says four […]
FDA clears painful diabetic neuropathy neurostim therapy from Neuralace
Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy […]
Nevro announces layoffs
Pain-treatment device company Nevro (NYSE:NVRO) announced that it is letting go of 63 employees, about 5% of its workforce, as part of a restructuring effort. “This restructuring supports our strategy and allows us to focus our investments to further position Nevro for long-term growth and profitability,” Nevro CEO Kevin Thornal said in a news release […]
Nalu Medical raises $65M for neurostim tech
Nalu Medical announced today that it closed a $65 million equity financing to support its minimally invasive neurostimulation product. Carlsbad, California–based Nalu had its round led by new investor Novo Holdings. All existing significant investors — including Gilde Healthcare, MVM Partners, Endeavor Vision, Decheng Capital, Longitude Capital, Advent Life Sciences, Pura Vida and Aperture Venture […]
SEC: former Stimwave CEO defrauded investors out of $41M with fake neuromod implant
The SEC charged Laura Perryman, former Stimwave CEO and co-founder, with defrauding investors out of approximately $41 million. Perryman founded and served as CEO of Florida-based Stimwave until her termination in 2019. In February 2020, Stimwave ceased all sales of its high-frequency spinal cord stimulation systems in exchange for the dismissal of a patent infringement lawsuit brought by […]