Outset Medical, Inc. Class Action Lawsuit - OM

(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.

In order to be eligible to join the OM class action lawsuit, you must have incurred a loss on shares of Outset Medical purchased during the class period listed above.

If you suffered a loss in Outset Medical during the relevant time frame, 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.