SAN FRANCISCO, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Hagens Berman urges Outset Medical, Inc. (NASDAQ:OM) investors who suffered substantial losses to submit your losses now.
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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 ...