Outset Medical Announces Shipment Hold on New Tablo Systems for Home Use Pending FDA Review and Clearance of Recent 510(K) Submission

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Jun 13, 2022

Outset Medical, Inc. (Nasdaq: OM) (“Outset” or the “company”) today announced 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.