Nula Medical’s offering is a drug-free alternative to chronic nerve or spine pain management. Image credit: adike via Shutterstock.

The US Food and Drug Administration (FDA) has granted an extended label clearance for whole-body MRI-conditional use to Nalu Medical’s neurostimulation system under its previously cleared indication for peripheral nerve stimulation (PNS) therapy.

The California-based company’s system received FDA 510(k) clearance for the indications of PNS and spinal cord stimulation (SCS) therapy in 2020. The solution is a drug-free approach to chronic pain management that uses mild electrical impulses intended to block pain signals from various parts of a patient’s body before they reach the brain.

The label extension means Nalu’s system can be offered to more patients without the risk of compromising diagnostic imaging needs that may arise in future.

Nalu Medical CEO and president Tom West commented: “This FDA clearance strengthens our mission to make peripheral nerve stimulation therapy appropriate for a broader patient population.

“With this expanded MRI-conditional labelling, more individuals seeking relief from chronic pain who may require a future MRI scan can confidently receive the near-term relief of Nalu’s clinically proven PNS therapy.”

Comprising an implantable pulse generator (IPG) a physician implants under the skin in the relevant region of the body and powered by a ‘therapy disc’ that rests on the skin above the implant and allows patients to control the intensity of the therapy via a smartphone app, Nalu positions the system as one to meet unmet needs in the treatment of chronic neuropathic pain.

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Commenting on the labelling expansion, Dr John A Hatheway at Northwest Pain Care said it allowed physicians to safely expand Nalu therapy usage to a wider audience and with fewer restrictions.

“This means more patients who might previously have been unsuitable for the therapy can now benefit from Nalu’s differentiated neurostimulation technology,” he commented.

According to an FDA report, peripheral neuropathy affects an estimated 20 million people in the US.

Last year, Nalu published a study evidencing that the use of its PNS therapy in chronic pain patients was associated with lower healthcare resource utilisation and a reduction in associated costs, including a 61% overall reduction in outpatient costs. The company also completed two Series E equity financing rounds totalling $150m in 2024.

Elsewhere in neurostimulation, Ireland’s Mainstay Medical published data earlier this month from a one-year study of its neurostimulation system for the treatment of chronic low back pain, which demonstrated the system’s value over the standard of care.