08:58 AM EDT, 07/21/2025 (MT Newswires) -- Takeda Pharmaceutical ( TAK ) said Monday it has received 510(k) clearance for its HyHub and HyHub Duo devices from the US Food and Drug Administration.

The devices reduce the number of steps required to prepare Hyqvia for infusion to patients 17 years and older in a home environment or clinical setting, the company said.

Hyqvia is a combination of immunoglobulin and hyaluronidase for the treatment of adults and children two years and older with primary immunodeficiency and as maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy, according to the statement.

Takeda said it expects to make HyHub and HyHub Duo available at no extra cost to patients in the US starting in H2.

The company said it also submitted a CE Mark application for the devices in the EU in Q1 and plans to evaluate making the devices available in other markets in the future.

Shares of Takeda were up more than 1% in recent premarket activity Monday.