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NeuroPace Wins FDA Nod for ECoG Assistant for Epilepsy Care

ECoG Assistant is the first in a suite of AI tools to support clinical decision making via deeper data insights and efficient ECoG review.

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By: Sam Brusco

Associate Editor

NeuroPace has obtained U.S. Food and Drug Administration (FDA) approval for ECoG Assistant, the company’s first artificial intelligence (AI)-driven clinician-enabled feature.

ECoG Assistant is the first in a suite of AI tools engineered to further support clinical decision making via deeper data insights and more efficient ECoG review. It was built on years of proprietary, patient-level data captured through the RNS System.

The ECoG Assistant model was developed on 124,450 epileptologist labeled iEEG long-episode records so it can identify ECoGs of Interest using the records. From a single view, physicians can review ECoG’s of Interest spanning months using a trends report and explore timing pattents and possible triggers using the Circadian Rhythm Chart.

“ECoG Assistant represents an important advancement in how clinicians interact with iEEG data and the RNS System,” said Dr. Martha Morrell, chief medical officer at NeuroPace. “By harnessing AI trained on a subset of the largest intracranial EEG dataset in the world, we are enabling faster access to insights that can support more efficient care and informed treatment decisions.”

NeuroPace plans to officially debut ECoG Assistant at the American Society for Stereotactic and Functional Neurosurgery (ASSFN) annual meeting.

“This approval underscores how NeuroPace’s data advantage is translating into practical tools for clinicians today,” said Joel Becker, CEO of NeuroPace. “AI-driven insights offer the unique potential to improve the efficiency of epilepsy care now while building a platform that can unlock new opportunities over time to further personalize therapy and improve outcomes.”

The company also submitted its next-gen Patient Data Management System (PDMS) for FDA review. The technology is designed to modernize the underlying software infrastructure supporting the RNS System. NeuroPace expects next-gen PDMS approval in the second quarter of this year.

Last month, the company released three-year effectiveness data from a post-approval study of the RNS System showing an 82% median reduction in seizures in adults with drug-resistance focal epilepsy.

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