Nalu Medical has earned U.S. Food and Drug Administration (FDA) clearance for expanded labeling on its peripheral nerve stimulation (PNS) system, which is now approved for whole-body MRI use.

The clearance allows better flexibility in treating chronic pain by minimizing MRI-related limitations. With the Nalu neurostimulation system’s expanded MRI status, the company said pain specialists can offer personalized care without compromising future diagnostic imaging needs.

“This FDA clearance strengthens our mission to make peripheral nerve stimulation therapy appropriate for a broader patient population,” said Tom West, president and CEO Nalu Medical. “With this expanded MRI-conditional labeling, 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.”

The Nalu neurostimulation system delivers gentle electrical pulses to the nervous systems to modulate pain signals before they reach the brain. It’s designed to address unmet needs in chronic neuropathic pain treatment.

“Whole-body MRI conditionality for the Nalu PNS System allows us to safely expand Nalu therapy usage to a wider audience with fewer restrictions,” said Dr. John A. Hatheway, Medical Director at Northwest Pain Care, PS. “This means more patients who might previously have been unsuitable for the therapy can now benefit from Nalu’s differentiated neurostimulation technology.”

In March 2024, the company released results of the SCS nPower U.S. clinical study that evaluated use of the Nalu SCS System to treat patients suffering from chronic intractable trunk and/or limb pain, including unilateral or bilateral pain.