secwatch.observer — SEC 8-K summary
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Issuer:     Outset Medical, Inc. (OM)
CIK:        0001484612
Form:       8-K
Filed at:   2022-06-13T23:59:59+00:00
Accession:  0000950170-22-011557
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Outset Medical halts home Tablo shipments pending FDA 510(k) review; guides Q2 rev at least $25M
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- Shipment hold on new Tablo Hemodialysis Systems for home use pending FDA 510(k) clearance of post-March 2020 changes.
- Q2 2022 revenue expected at least $25M; prior FY2022 guidance suspended until early August update.
- No safety issues identified; Tablo continues to sell for chronic and acute care settings.
- Already-distributed home devices not removed; current users can continue treatment with providers.
- Company expects update on regulatory review process in Q3 2022.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1484612/000095017022011557/0000950170-22-011557-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1484612/000095017022011557/om-20220613.htm
  HTML page:      https://secwatch.observer/filing/0000950170-22-011557

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