Story · FDA
NeuroPace Discusses FDA Feedback on PMA Supplement for IGE Indication Expansion
NeuroPace held a conference call to discuss the status of its PMA Supplement seeking FDA approval to expand the indication for its RNS System to include patients with antiseizure medication-resistant idiopathic generalized epilepsy (IGE). The call featured CEO Joel Becker and Chief Medical Officer Dr. Martha Morrell, with CFO Patrick Williams also present. The company had issued a press release earlier that day providing an update on the regulatory process. The call included forward-looking statements regarding FDA review expectations and the company's submission strategy. This update is significant for NeuroPace as it seeks to broaden the market for its RNS neurostimulation device beyond its current approved indications.
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