LOS ANGELES, CA / ACCESSWIRE / August 18, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Outset Medical, Inc. ("Outset Medical" or "the Company") (NASDAQ:OM) for violations of the securities laws.
The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Outset Medical disclosed in an SEC filing on July 7, 2023, that, "on 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 Company disclosed that, "the FDA issued an FDA Form-483 identifying four inspectional observations resulting from an FDA inspection that concluded on February 10, 2023" and that "the 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."
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The class in this case has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.
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CONTACT:
The Schall Law Firm
Brian Schall, Esq.
310-301-3335
[email protected]
www.schallfirm.com
SOURCE: The Schall Law Firm