08:48 AM EDT, 05/06/2024 (MT Newswires) -- Outset Medical ( OM ) said Monday that the US Food and Drug Administration has granted 510(k) clearance for TabloCart with prefiltration, an optional accessory to its Tablo Hemodialysis System dialysis machine.

The medical technology company said it has resumed distribution of TabloCart with prefiltration and has product available to ship to customers in the US.

Shares of Outset Medical ( OM ) were up nearly 13% in recent Monday premarket activity.

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