11:40 AM EDT, 05/06/2024 (MT Newswires) -- (Updates with the latest stock price movement in the headline and first paragraph.)

Outset Medical ( OM ) shares were up nearly 40% in recent Monday trading after the company said 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.

Price: 4.38, Change: +1.24, Percent Change: +39.49