- Price
- $14.14
- Day
- +4.74%
- Mkt Cap
- $482.09M
- 52W Range
- $7.56 – $19.60
- Volume
- 274.6K
- Beta
- 1.94
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NeuroPace, Inc. (NPCE) Discusses FDA Feedback on PMA Supplement for Indication Expansion into Idiopathic Generalized Epilepsy Transcript
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MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today provided an update on the U.S. Food and Drug Administration review of the Company's Premarket Approval Panel Track Supplement seeking to expand the labeled indication for the RNS® System to include patients with antiseizure medication-resistant idiopathic generalized epilepsy (IGE). NeuroPace has received a communication from FD.
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NeuroPace NASDAQ: NPCE said the U.S. Food and Drug Administration determined that its premarket approval supplement seeking to expand the RNS System indication to patients with medication-resistant idiopathic generalized epilepsy, or IGE, was not approvable in its current form.
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NPCE's RNS adoption, referral growth and AI innovation support expansion, while IGE timing and investments may pressure near-term profits.
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