NeuroPace Receives the US FDA Approval for ECoG Assistant to Advance AI-Driven Epilepsy Care
Shots:
- The US FDA has approved ECoG Assistant, an AI-powered clinician tool designed to support epilepsy management using data from the RNS System, with NeuroPace debuting the tool at ASSFN’26
- ECoG Assistant was developed using 124,450 epileptologist-labeled intracranial EEG records & identifies ECoGs of Interest, enabling clinicians to review long-term EEG trends & circadian activity patterns more efficiently
- NeuroPace also submitted its cloud-based Patient Data Management System (PDMS) for FDA review to modernize the underlying software infrastructure that supports the RNS System, with decision expected in Q2’26
Ref: Businesswire | Image: NeuroPace | Press Release
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