Press release

HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS, Encourages Outset Medical (OM) Shareholders with Losses to Contact its Attorneys, Firm Investigating Possible Securities Law Violations

SAN FRANCISCO, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Hagens Berman urges Outset Medical, Inc. (NASDAQ:OM) investors who suffered substantial losses to submit your losses now.

Contact An Attorney Now:

Outset Medical, Inc. (NASDAQ:OM) Investigation:

The investigation focuses on the propriety of Outset Medical's disclosures concerning marketing authorizations and commercialization of its flagship dialysis device, the Tablo Hemodialysis System ("Tablo").

On June 13, 2022, when Outset revealed that in late May it implemented a shipment hold on Tablo for home use pending the FDA's review and clearance of its 510(k) application, its 510(k) submission did not include data obtained through real-world human testing consistent with the FDA-approved protocol. As a result, Outset suspended 2022 and long-term financial guidance.

In late July 2022, Outset disclosed the FDA cleared the 510(k) application of Tablo for patient use in the home.

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