Stimwave LLC announces that its StimQ Peripheral Nerve Stimulator (PNS) System has received 510(k) clearance from the US Food and Drug Administration.
The wireless, micro-technology neuromodulation device is designed to enable ongoing full-body MRI scans under certain conditions for the relief of chronic peripheral nerve pain.
“Thanks to our revolutionary wireless device, we are the only neuromodulation company cleared by the FDA to help patients reduce their chronic neuropathic pain by pinpointing stimulation directly to the affected peripheral nerves with a multi-electrode programmable device, which enables ongoing MRI scans,” says Stimwave Chairman and CEO Laura Tyler Perryman, in a media release.
The device—implanted via a minimally invasive outpatient procedure and powered by a wearable external unit—delivers small pulses of energy to electrodes placed at a peripheral nerve, enabling the brain to remap specific pain signals and relieve pain.
[Source(s): Stimwave LLC, Business Wire]