{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-053108","form_type":"8-K","ticker":"OM","cik":"0001484612","company_name":"Outset Medical, Inc.","filed_at":"2023-10-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.209223+00:00","generated_at":"2026-06-10T00:39:05.724510+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Outset Medical prelim Q3 rev $30.4M (+9% YoY); FY23 guidance cut to ~$130M on FDA letter headwind","bullets":["Preliminary Q3 revenue $30.4M (+9% YoY), gross margin 23.6% (25.6% non-GAAP).","FY23 revenue guidance lowered to ~$130M, citing FDA warning letter impact and cautious capex outlook.","Cash and investments $197M as of Sept. 30, 2023.","CEO notes no deal losses but headwinds expected into Q4; confidence in long-term growth and profitability."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-053108","json":"https://secwatch.observer/filing/0000950170-23-053108.json","markdown":"https://secwatch.observer/filing/0000950170-23-053108.md","text":"https://secwatch.observer/filing/0000950170-23-053108.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1484612/000095017023053108/0000950170-23-053108-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1484612/000095017023053108/om-20231012.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T00:39:05.724510+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[{"claim_id":"753321c0f745b0a9a883a4d334af2742ed5d9d91","claim":"Outset Medical, Inc. updated its third quarter ended Sept. 30, 2023 guidance (reaffirmed).","evidence_excerpt":"On October 12, 2023, Outset Medical, Inc. (the “ Company ”) issued a press release announcing expected revenue and gross margin for the third quarter ended September 30, 2023, as well as updated financial guidance for 2023 revenue.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1484612/000095017023053108/0000950170-23-053108-index.htm","confidence":0.4,"family_label":"Earnings Releases","details":[{"label":"Period","value":"third quarter ended Sept. 30, 2023"},{"label":"Guidance","value":"reaffirmed"},{"label":"Result","value":"preliminary results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}