NeuroPace announced today that FDA approval of MRI labeling for its RNS system for people living with seizures that do not respond to medication.

The Mountain View, Calif.–based company touts its RNS system as the world’s only closed-loop brain-responsive neurostimulation system designed to prevent seizures at their source. It includes a neurostimulator, leads placed at the seizure foci, a remote monitor for uploading data and an RNS tablet and patient data management system for physicians to view data on a secure website and use to personalize therapy.

RNS system treatment in a real-world study recorded median seizure frequency reduction of 82% at three years, while one in three patients achieved 90% or greater seizure reduction, according to the company.

The FDA approval is set to allow RNS system treatment for patients with non-brain MRI requirements now, adding it to the list alongside individuals with focal onset seizures that also have brain anomalies that require monitoring, like tuberous sclerosis brain tumors or multiple sclerosis. NeuroPace said the latest approval allows people to receive RNS system treatment before committing to irreversible surgeries like laser ablation.

“MRI conditional labeling opens up valuable medical imaging possibilities for our patients treated with the model RNS-320 neurostimulator, who can now receive full-body 1.5T magnetic resonance imaging (MRI) scans under appropriate conditions,” NeuroPace president & CEO Michael Favet said in the release. “I’m pleased that we have removed a potential barrier to treatment and increased the number of patients who can benefit from this life-changing therapy.”

Dr. David Burdette, the section chief of epilepsy at Spectrum Health (Grand Rapids, Mich.), described the FDA approval as wonderful news for the many people living with refractory epilepsy. “This therapy not only reduces seizures, it also empowers clinicians with data-driven insights into their patients’ epilepsy.”