FDA Approves NeuroPace’s Neurostimulator for MRIs

NeuroPace’s brain-responsive neurostimulation system has earned FDA approval for treatment of patients with focal seizures in addition to brain anomalies that require MRI monitoring, as well as those with non-brain MRI requirements.

The RNS System is the only epilepsy treatment that captures direct, real-world EEG data, enabling clinicians to optimize the therapy.

The approval will allow patients to “receive the RNS System before committing to an irreversible surgery such as laser ablation, ” the company said.