{"filing":{"accession_number":"0001193125-26-321083","cik":"0001528287","ticker":"NPCE","company_name":"NeuroPace Inc","form":"8-K","filing_date":"2026-07-28","report_date":"2026-07-28","primary_document":"d138221d8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1528287/000119312526321083/d138221d8k.htm"},"events":[{"id":21161,"run_id":19074,"accession_number":"0001193125-26-321083","anchor_item_number":"7.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"NeuroPace received FDA notification that its Premarket Approval Supplement (PMA-S) for indication expansion into idiopathic generalized epilepsy is \"not approvable in its current form\" and requires additional clinical evidence. This is a material regulatory setback for a key product expansion that directly impacts the company's growth strategy and market access. While not a formal denial, the non-approvability determination is a significant operational and regulatory milestone that would affect investor assessment of the company's near-term commercial prospects and pipeline execution.","company_name":"NeuroPace Inc","ticker":"NPCE","filing_date":"2026-07-28","form":"8-K","submitted_at":null,"items":[{"id":20722,"accession_number":"0001193125-26-321083","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"NeuroPace received FDA notification that its Premarket Approval Supplement (PMA-S) for indication expansion into idiopathic generalized epilepsy is \"not approvable in its current form\" and requires additional clinical evidence. This is a material regulatory setback for a key product expansion that directly impacts the company's growth strategy and market access. While not a formal denial, the non-approvability determination is a significant operational and regulatory milestone that would affect investor assessment of the company's near-term commercial prospects and pipeline execution.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-28T20:34:06.853645+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":20722,"accession_number":"0001193125-26-321083","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"NeuroPace received FDA notification that its Premarket Approval Supplement (PMA-S) for indication expansion into idiopathic generalized epilepsy is \"not approvable in its current form\" and requires additional clinical evidence. This is a material regulatory setback for a key product expansion that directly impacts the company's growth strategy and market access. While not a formal denial, the non-approvability determination is a significant operational and regulatory milestone that would affect investor assessment of the company's near-term commercial prospects and pipeline execution.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-28T20:34:06.853645+00:00","company_name":"NeuroPace Inc","ticker":"NPCE","filing_date":"2026-07-28"}]}