Fresenius Medical Care announced today that it received FDA clearance for its 5008X hemodialysis system. The company said this marks a step toward bringing a new standard of care in dialysis therapy to the U.S. Bad Homburg, Germany-based Fresenius can now begin U.S.-based clinical evaluations and user studies ahead of a broad launch in 2025. […]
Fresenius Medical Care
Fresenius notches AI milestone in clinical dialysis dataset
Fresenius Medical Care announced the completion of phase one of its first anonymized global dialysis dataset as part of its long-term AI aspirations. The Apollo database project aims to advance patient care quality and outcomes by making kidney disease care more personalized and precise. It provides a view into the clinical care provided to more […]
Fresenius Medical Care has a Class I recall of some hemodialysis machines
The FDA issued a notice declaring a recall of some Fresenius Medical Care hemodialysis machines as Class I, the most serious kind. Fresenius Medical Care recalled some of its 2008 Series hemodialysis machines that may cause exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) that leach from some peroxide-cured silicone tubing used as part of […]
FDA clears software for Fresenius home hemodialysis system
Fresenius Medical Care announced today that the FDA granted 510(k) clearance for its Versi HD with GuideMe software. The completely reinvented, self-guided interface serves Fresenius’ VersiHD chronic home hemodialysis (HHD) system. It aims to transform the experience of HHD for both patients and nurses. Fresenius Medical Care’s NxStage designed VersiHD with GuideMe to provide graphical […]
Fresenius Medical Care stock dips on mixed Q2 results
Fresenius Medical Care shares fell this morning on second-quarter results that came in mixed compared to the consensus forecast. Shares of FMS were down 2% at $25.33 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell by nearly 1%. The Germany-based dialysis […]
Fresenius Medical Care converts to German stock corporation to simplify corporate structure
Fresenius Medical Care announced today that an Extraordinary General Meeting (EGM) saw shareholders approve a change to corporate structure. The renal disease treatment product provider’s shareholders approved all EGM agenda meetings with a large majority. One major approval was the conversion of Fresenius Medical Care from the legal from of a partnership limited by shares […]
Fresenius Medical Care appoints new CFO
Fresenius Medical Care announced today that it appointed Martin Fischer as its new chief financial officer (CFO). Fischer’s appointment goes into effect on Oct. 1, 2023. He succeeds Helen Giza, who took over as CEO and board chair in December 2022. She took on the corner office after CEO Carla Kriwet decided to leave the […]
Fresenius Medical Care joins health equity pledge
Fresenius Medical Care announced today that it joined the Zero Health Gaps Pledge at the World Economic Forum in Davos, Switzerland. As part of the Global Health Equity Network (GHEN), the pledge brings together stakeholders from the public and private sectors. In line with the UN Sustainable Development Goals, they aim to advance a collective […]
Fresenius Medical Care’s CEO leaves after two months in top spot
Fresenius said Fresenius Medical Care (NYSE:FMS) CEO Carla Kriwet will leave the company “at her own request and by mutual agreement due to strategic differences.” The Bad Homburg, Germany-based dialysis provider instead named Deputy CEO and CFO Helen Giza as the division’s next CEO. When announcing Kriwet’s promotion and Giza’s new role of deputy CEO […]
FDA clears heat purification, remote therapy from Fresenius
Fresenius Medical Care North America (FMCNA) recently announced FDA clearances for two of its technologies used in dialysis care. Today, the Waltham, Massachusetts-based company announced FDA clearance for the AquaA water system. The company designed it as a water purification system for hemodialysis. Yesterday, the FDA granted 510(k) clearance to upgrade Fresenius’ Liberty Select cycler. […]
Fresenius’ NxStage launches Speedswap for critical care dialysis
Fresenius Medical Care North America’s renal therapies group announced today that it launched the Speedswap for the NxStage System One with NxView. Speedswap, a new option for the NxStage System One with NxView, enables the changing of a flow-compromised dialysis filter without replacing the entire cartridge. According to a news release, Fresenius designed the new […]