The clearance gives physicians greater flexibility in treating chronic pain, minimizing MRI-related limitations with whole-body MRI-conditional use. Nalu’s system now enables personalized care without compromising future diagnostic imaging needs.
Carlsbad, California–based Nalu offers FDA-cleared spinal cord stimulation and peripheral nerve stimulation technology. It designed its offerings to treat patients with chronic neuropathic pain. It delivers gentle electrical pulses to the nervous system to modulate pain signals before they reach the brain.
Nalu’s system includes a fully featured, battery-free, miniaturized implantable pulse generator (IPG). An externally worn therapy disc wirelessly powers the IPG and the user can control it through a smartphone-based app. The company says its IPG, despite its smaller size, delivers treatment capabilities similar to larger IPGs. Nalu’s system also has an expected service life of 18 years.
With whole-body MRI conditionality, the therapy can reach a wider audience with fewer restrictions.
“This FDA clearance strengthens our mission to make peripheral nerve stimulation therapy appropriate for a broader patient population,” said Tom West, CEO and president. “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.”
Nalu Medical featured on MassDevice’s 2024 list of neurotech companies you need to know.
