SHAREHOLDER ACTION NOTICE: The Schall Law Firm Announces it is Investigating Claims Against Outset Medical, Inc. and Encourages Investors with Losses In Excess of $100,000 to Contact the Firm

PRESS RELEASE
Published July 25, 2023

LOS ANGELES, CA / ACCESSWIRE / July 25, 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 Schall Law Firm, Tuesday, July 25, 2023, Press release picture

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."

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at bschall@schallfirm.com.

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.

The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

CONTACT:

The Schall Law Firm
Brian Schall, Esq.,
www.schallfirm.com
Office: 310-301-3335
info@schallfirm.com

SOURCE: The Schall Law Firm



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