Outset Medical, Inc.

Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Outset Medical, Inc. (NASDAQ: OM) resulting from allegations that Outset Medical may have issued materially misleading business information to the investing public.

If you purchased Outset Medical securities and would like to join the prospective action, please click “Join This Class Action.”

If you purchased Outset Medical securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

Details of investigation:

On July 7, 2023, Outset Medical disclosed in a filing with the U.S. Securities and Exchange Commission that “[o]n July 6, 2023, Outset Medical, Inc. (the ‘Company’) received a Warning Letter, dated July 5, 2023 (the ‘Warning Letter’), from the United States Food and Drug Administration (the ‘FDA’).” The filing stated that, as previously disclosed in the Company’s annual report, “the FDA issued an FDA Form-483 identifying four inspectional observations resulting from an FDA inspection that concluded on February 10, 2023” and that “[t]he Warning Letter raises two additional observations. The first observation asserts that certain materials reviewed by the FDA and found on the Company’s website promote continuous renal replacement therapy (CRRT), a modality outside of the current indications for the Tablo® Hemodialysis System. The Company believes this concern has been effectively addressed through labeling and promotional changes already underway. The second observation asserts that the TabloCart with Prefiltration (the ‘TabloCart’), requires prior 510(k) clearance for marketing authorization. . . . The Company intends to work collaboratively with the FDA to resolve this observation, including potentially submitting a 510(k) on TabloCart.”

On this news, Outset Medical’s stock price fell $1.20 per share, or 5.87%, to close at $19.26 per share on July 10, 2023.

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Company Name: Outset Medical, Inc.
Stock Symbol: OM
Class Period: N/A
Court: N/A

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