San Diego, CA -- (SBWIRE) -- 08/16/2022 -- An investor, who purchased shares of Outset Medical, Inc. (NASDAQ: OM), filed a lawsuit over alleged Securities Laws violations by Outset Medical, Inc..

Investors who purchased shares of Outset Medical, Inc. (NASDAQ: OM) have certain options and for certain investors are short and strict deadlines running. Deadline: September 6, 2022. NASDAQ: OM investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

San Jose, CA based Outset Medical, Inc., a medical technology company, develops a hemodialysis system for dialysis. On June 13, 2022, Outset Medical, Inc. announced that "it has implemented a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending the Food and Drug Administration's (FDA) review and clearance of a 510(k) the company submitted for changes made since the device's original March 2020 clearance."

Shares of Outset Medical, Inc. (NASDAQ: OM) declined from $40.51 per share on May 4, 2022, to as low as $13.25 per share on June 14, 2022.

The plaintiff claims that between September 15, 2020 and June 13, 2022, the Defendants misled investors and/or failed to disclose that Defendants had "continuously made improvements and updates to Tablo over time since its original clearance" that required an additional 510(k) application, that as a result, the Company could not conduct a human factors study on a cleared device in accordance with FDA protocols, that 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 that 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.

Those who purchased shares of Outset Medical, Inc. (NASDAQ: OM) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About The Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.