Levi & Korsinsky, LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or otherwise acquired Outset Medical, Inc. (NASDAQ: OM) securities.
If you suffered a loss on your Outset Medical investment and would like to explore a potential recovery under the federal securities laws, submit to us or contact Joseph E. Levi, Esq. via email at [email protected] or call 212-363-7500 to speak to our team of experienced shareholder advocates.
THE LAWSUIT: common stock between September 15, 2020, and June 13, 2022
CASE DETAILS:
(1) the Company’s flagship product, Tablo Hemodialysis System (“Tablo”), would require an additional 510(k) application to be filed with The United States Food and Drug Administration (“FDA”), as defendants had “continuously made improvements and updates to Tablo over time since its original clearance”; (2) as a result, the Company could not conduct a human factors study on a cleared device in accordance with FDA protocols; (3) the Company’s inability to conduct the human factors study subjected the Company to the likelihood of the FDA imposing a “shipment hold” and marketing suspension, leaving the Company unable to sell Tablo for home use; and (4) as a result, defendants’ positive statements about the Company’s business, operations, and prospects were materially false and misleading and /or lacked a reasonable basis at all relevant times.
Please provide your address so we can contact you about your case if eligible.






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