Fresenius Medical Care launches FDA‑cleared multiFiltratePRO kidney system in the U.S.
Fresenius Medical Care announced the U.S. launch of its multiFiltratePRO continuous kidney replacement therapy system for critically ill patients with acute kidney injury. The FDA granted clearance on October 19, 2026 and approved the accompanying Cienby sodium citrate and Calrezdy calcium solutions for regional citrate anticoagulation. The system integrates citrate and calcium pumps, removing the need for separate infusion devices, and automatically adjusts infusion rates as treatment conditions change.
Why it matters
The clearance adds the first FDA‑approved CKRT platform that supports regional citrate anticoagulation, expanding treatment options for intensive‑care units in the United States. The company expects the controlled rollout to move quickly to full availability, potentially increasing its market share in the U.S. kidney‑care segment.
Key facts
- 1The U.S. Food and Drug Administration cleared the multiFiltratePRO system on October 19, 2026. prnewswire.com
- 2The clearance also approved Cienby sodium citrate and Calrezdy calcium chloride solutions for on‑label regional citrate anticoagulation. prnewswire.com
- 3The system integrates citrate and calcium pumps, eliminating the need for separate external infusion pumps. stocktitan.net
- 4Infusion rates automatically adjust to changes in blood and effluent flow to maintain protocol‑defined ratios. prnewswire.com
- 5The approved solutions are indicated for patients weighing at least 40 kg, including adults and children. prnewswire.com
- 6Joe Turk, CEO of Care Enablement at Fresenius Medical Care, said the launch reflects the company’s commitment to bring innovative kidney‑care solutions to new markets. prnewswire.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.