NEW YORK, July 10, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Outset Medical, Inc. (“Outset Medical” or the “Company”) (NASDAQ: OM). Such investors are advised to contact Robert S. Willoughby at newaction@pomlaw.com or 888-476-6529, ext. 7980.
The investigation concerns whether Outset Medical and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
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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.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.
CONTACT:
Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
888-476-6529 ext. 7980
