NEW YORK, NY / ACCESSWIRE / July 11, 2023 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Outset Medical, Inc. ("Outset Medical" or the "Company") (NASDAQ:OM). Investors who purchased Outset Medical securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: www.bgandg.com/om.
The investigation concerns whether Outset Medical has violated federal securities laws.
Investigation Details:
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.
What's Next?
If you are aware of any facts relating to this investigation or purchasedOutset Medical shares, you can assist this investigation by visiting the firm's site: www.bgandg.com/om. You can also contact Peretz Bronstein or his law clerk and client relations manager, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.
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Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that represents investors in securities fraud class actions and shareholder derivative suits. Our firm has recovered hundreds of millions of dollars for investors nationwide.
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Contact:
Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Yael Nathanson
212-697-6484 | [email protected]
SOURCE: Bronstein, Gewirtz & Grossman, LLC