March 2026 Fresenius Medical Care received FDA 510(k) clearance for an updated version of its 5008X CAREsystem, supporting the commercialization of high-volume hemodiafiltration therapy in the U.S.
February 2026 Outset Medical received FDA 510(k) clearance for the updated Tablo Hemodialysis System software, enhancing dialysis workflow efficiency and patient management.
June 2025 Fresenius Medical Care began broader U.S. commercialization of the 5008X CAREsystem after receiving FDA clearance, advancing the rollout of high-volume hemodiafiltration therapy.
May 2025 Nipro Medical expanded its dialysis manufacturing capabilities through investments in production capacity for dialysis products and consumables to support growing global demand.