---
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"
generated_at: "2026-06-10T00:39:05.724510+00:00"
event_type: "earnings"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Outset Medical prelim Q3 rev $30.4M (+9% YoY); FY23 guidance cut to ~$130M on FDA letter headwind

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: earnings
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 2.02, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-053108
- JSON: https://secwatch.observer/filing/0000950170-23-053108.json
- Plain text: https://secwatch.observer/filing/0000950170-23-053108.txt

## Key facts
- Earnings Releases
  Outset Medical, Inc. updated its third quarter ended Sept. 30, 2023 guidance (reaffirmed).
  - Period: third quarter ended Sept. 30, 2023
  - Guidance: reaffirmed
  - Result: preliminary results
  source text: 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_url: https://www.sec.gov/Archives/edgar/data/1484612/000095017023053108/0000950170-23-053108-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.