- In June 2025, Fresenius Medical Care secured FDA 510(k) clearance for its updated 5008X CAREsystem, enabling high-volume hemodiafiltration (HVHDF) in the U.S. The system is being deployed in a phased manner throughout Fresenius Kidney Care clinics in 2025, with full commercial launch expected in 2026. The 5008X CAREsystem introduces Clinical Data Exchange (CDX), streamlining digital workflows and allowing seamless access to electronic medical records at the patient’s chairside
- In March 2025, the U.S. FDA announced a critical shortage of hemodialysis bloodlines, forecasting the supply issue to persist through early fall 2025. The FDA urged clinicians to implement conservation measures to maintain continuity of care for ESRD patients receiving hemodialysis. The shortage affected multiple healthcare networks, prompting resource optimization strategies
- In November 2024, Quanta Dialysis Technologies received FDA 510(k) clearance for its Quanta Dialysis System, marking it the only high dialysate-flow (500 mL/min) home-use dialysis device approved in the U.S. This advancement allows hospital-grade performance in home settings, providing ESRD patients greater flexibility and independence. The device’s compact design and automated functionality are key to enabling at-home high-efficiency treatments
- In July 2024, Roche announced the successful acquisition of LumiraDx’s Point of Care technology, following the necessary antitrust and regulatory approvals. This integration enhanced Roche’s diagnostics portfolio with a user-friendly platform that consolidates various immunoassay and clinical chemistry tests. The acquisition aimed to improve access to diagnostic testing, particularly in primary care and underserved regions, aligning with Roche's commitment to decentralised healthcare solutions
- In May 2023, Thermo Fisher and BRIN have partnered to enhance research capabilities in Indonesia, focusing on advancing scientific innovation and collaboration in life sciences, biotechnology, and environmental studies for local researchers
- In August 2024, MilliporeSigma, the Life Science business of Merck KGaA, Darmstadt, Germany, has completed its acquisition of Mirus Bio for approximately USD 600 million. This strategic move enhances MilliporeSigma's viral vector bioprocessing capabilities, integrating Mirus Bio's advanced transfection reagents with their extensive bioprocessing portfolio to support cell and gene therapy advancements.
