WHY: New York, NY - 
(NewMediaWire) - August 06, 2023 - Rosen Law Firm, a global investor rights law firm, continues to investigate 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.
WHAT TO DO NEXT: To join the prospective class action, go to https://rosenlegal.com/submit-form/?case_id=17760 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.
WHAT IS THIS ABOUT: 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.
WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.
Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.
Attorney Advertising. Prior results do not guarantee a similar outcome.
-------------------------------
Contact Information:
Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com
