Baxter today shared an update on the planned separation of its Kidney Care business as it looks at a potential sale instead of a spinoff. In January 2023, Baxter announced plans to spin its renal care and acute therapies units into an independent, publicly traded company. It said at the time that it expected the […]
Dialysis
FDA clears 5008X hemodialysis system from Fresenius Medical Care
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. […]
Baxter beats The Street in Q4, kidney care spin progresses
Baxter shares ticked up today on fourth-quarter results that came in ahead of the consensus forecast. Shares of BAX rose 1.2% at $39.87 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — dipped 0.2%. The Deerfield, Illinois-based company posted profits of $245 million. […]
The top medtech trends of 2023
The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods. With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more. Here are the top stories […]
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 […]
Outset Medical stock plummets amid warning letter woes
Outset Medical has slashed its full-year revenue outlook as the maker of Tablo hemodialysis systems grapples with an FDA warning letter. The company now expects roughly $130 million in revenue in 2023 — down from its previous forecast of $144–150 million. It’s preliminary numbers show third-quarter sales up 9% year-over-year to $30.4 million. Cash, cash […]
SeaStar wins FDA breakthrough nod for selective cytopheretic device
SeaStar Medical (Nasdaq:ICU) announced today that the FDA granted breakthrough device designation for its selective cytopheretic device (SCD). Denver-based SeaStar designed the SCD for use in patients in the intensive care unit (ICU) with acute or chronic systolic heart failure. These patients have worsening renal function due to cardiorenal syndrome or right ventricular dysfunction. They’re awaiting […]
Awak raises $20M Series B for wearable dialysis device
Awak Technologies announced today that it raised $20 million in Series B funding to support its dialysis technology. The Singapore-based company designed Awak PD as a wearable and ultraportable peritoneal dialysis (PD) system. It offers patients the freedom to undergo dialysis at home and anywhere on the go. It helps to overcome the challenge 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 […]
Teleflex extends Arrow ErgoPack system with hemodialysis, large bore catheters
Teleflex announced today that it released its Arrow ErgoPack complete kits with hemodialysis and larbe bore catheters in the U.S. Wayne, Pennsylvania-based Teleflex launched this update to streamline insertion workflow for clinicians. The company also says it provides more options to suit their particular needs. Get the full story at our sister site, Medical Tubing […]