Class Action Reports

OM Class Action: Learn About the Outset Medical Lawsuit

Levi & Korsinsky, LLP

July 12, 2022

Levi & Korsinsky, LLP announces that an OM class action lawsuit has been filed on behalf of investors who purchased Outset Medical, Inc. (OM) securities between September 15, 2020, and June 13, 2022. For more on the OM Lawsuit please contact us today.





According to the Outset Medical lawsuit, throughout the Class Period defendants made false and/or misleading statements and/or failed to disclose that:(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 perform 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.




If you suffered a loss in Outset Medical you have until September 6, 2022, to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as a lead plaintiff.



Levi & Korsinsky, LLP

Joseph E. Levi, Esq.

55 Broadway, 10th Floor

New York, NY 10006

Tel: (212) 363-7500

Fax: (212) 363-7171