Outset Medical(US:OM) Prnewswire·2024-09-23 09:45Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Outset Medical, Inc. regarding a class action lawsuit alleging misleading statements and omissions related to the company's Tablo products used in dialysis care [1]. Group 1: Allegations - The complaint claims that during the class period from August 1, 2022, to August 7, 2024, Outset Medical made materially false and misleading statements about its Tablo products [1]. - It is alleged that the Tablo products were marketed for continuous renal replacement therapy, which is not FDA-approved, indicating potential regulatory issues [1]. - The company may need to submit an additional 510(k) application for the Tablo products, raising concerns about the continuation of sales pending FDA approval [1]. - There is a significant risk that Outset Medical would halt sales of the Tablo products until additional indications are approved by the FDA [1]. - The company reportedly lacks the necessary sales team and processes to effectively ramp up Tablo sales, which could adversely affect revenue growth [1]. - Due to these factors, the positive statements made by the defendants regarding the company's business and prospects were deemed materially misleading [1]. Group 2: Next Steps for Shareholders - Shareholders who purchased shares of Outset Medical during the specified class period are encouraged to register for the class action by October 28, 2024 [2]. - Upon registration, shareholders will be enrolled in a portfolio monitoring system to receive updates on the case's progress [2]. - There is no cost or obligation for shareholders to participate in this class action [2].