09:15 AM EDT, 07/03/2024 (MT Newswires) -- SeaStar Medical Holding ( ICU ) said Wednesday that the US Food and Drug Administration has agreed to the final labeling for its Quelimmune device to treat children with acute kidney injury and sepsis or septic condition requiring kidney replacement therapy.

The commercial-stage medical technology company said the final labeling paves the way under the Humanitarian Use Device designation to market the therapeutic device in the US.

The company said it expects to begin shipping this month.

Shares of SeaStar Medical ( ICU ) were up more than 9% in recent Wednesday premarket activity.

Price: 9.50, Change: +0.63, Percent Change: +7.10