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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.

But on July 7, 2023, Outset Medical disclosed that it received an FDA Warning Letter asserting that: (1) the company’s website promotes a modality outside of current indications for Tablo; and (2) another 510(k) application was required for marketing authorization regarding TabloCart with Prefiltration (an accessory to the Tablo system).

More recently, on Oct. 12, 2023, Outset Medical reported disappointing preliminary Q3 2023 revenues and slashed its FY 2023 revenue guidance. The company blamed the shortfall on “a larger-than-expected impact in the field from the recent FDA warning letter, which served to elongate our sales cycle in several ways.”

These events have driven the price of Outset Medical shares sharply lower and recently prompted at least one analyst to double downgrade the company’s shares.

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