The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used in Fresenius Medical Care (NYSE: FMS) hemodialysis machines. The investigation concerns three models of Fresenius hemodialysis machines: the 2008T, 2008K2, and 2008K. The chemicals — non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) — are in the […]
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Fresenius Medical Care (NYSE: FMS) has hired Carla Kriwet as its next CEO, effective Jan. 1, 2023. Kriwet will replace Rice Powell, who will step down on Dec. 31 after hitting the company’s age limit. Powell is 66. Kriwet is 51. “I fully identify with the vision of making the lives of the patients who […]
ReWalk Robotics (Nasdaq:RWLK) announced that it appointed Joseph Turk, Jr. to its board of directors. The appointment was made effective on April 20. Turk joins the Marlborough, Massachusetts-based robotic medical technology developer having begun his career at McKinsey and Company before joining Boston Scientific as its director of new business development. He also held leadership […]
Fresenius Medical Care announced today it received FDA 510(k) clearance for its next-generation Versi PD cycler system. The company designed the portable automated peritoneal dialysis (APD) system (from Fresenius Medical Care North America) as a light, simple, quiet, portable and advanced platform for improving health equity by making home therapy a more feasible option for […]
Koru Medical Systems (Nasdaq:KRMD) announced that it appointed medtech veteran Brian Case as its new chief technology officer. With more than 20 years of experience in medtech R&D, Case joins after spending more than 16 years at Fresenius Kabi as VP of R&D. Before Fresenius Kabi, he served as an R&D program manager for advanced […]
Fresenius Kabi announced today that it will acquire Ivenix with plans to bring a comprehensive infusion product portfolio to the U.S. The acquisition, which has a purchase price of $240 million upfront, also includes potential milestone payments linked to achievements of commercial and operating targets. Get the full story at our sister site, Drug Delivery Business News.
Fresenius Medical Care announced today that it entered into an agreement to create a new company for providing kidney care. The agreement involves Fresenius Health Partners, Fresenius Medical Care North America’s value-based care division, entering into a combination with InterWell Health and Cricket Health. Both InterWell and Cricket represent U.S.-based kidney care providers, with Interwell […]
Fresenius SE & Co. KGaA announced today that it plans for Siemens Healthineers executive Dr. Christoph Zindel to join its Supervisory Board. Zindel will stand for election at Fresenius’ Annual General Meeting on May 13. A member of Siemens Healthineer’s managing board, Zindel’s responsibilities at the German medtech giant include imaging, advanced therapies, technology excellence, […]
Fresenius Kabi announced today that it received FDA 510(k) clearance for its wireless Agilia Connect infusion system. Lake Zurich, Illinois–based Fresenius Kabi’s Agilia Connect infusion system includes the Agilia volumetric pump and the Agilia syringe pump with Vigilant software suite-Vigilant Master Med technology. Get the full story at our sister site, Drug Delivery Business News.
Fresenius Kabi USA announced today that it initiated the voluntary recall of seven lots of its sodium acetate injection. Lake Zurich, Illinois-based Fresenius Kabi recalled the USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or […]
The U.S. Cyber Security & Infrastructure Security Agency today issued a medical advisory for the Fresenius Kabi Agilia Connect infusion system. Fresenius Kabi’s Agilia Connect infusion system has been deemed “exploitable remotely/low attack complexity” by the agency. Successful exploitation of vulnerabilities could allow an attacker to gain access to sensitive information, modify settings or parameters or perform […]