The FDA says a recall of Fresenius Medical Care catheter extension sets and luer lock adapters is Class I, the most serious kind. Fresenius Medical Care initiated the recall of a number of its Stay-Safe luer lock adapters and catheter extensions on Jan. 23, 2024. It extends to nearly 2.2 million devices distributed between March […]
Dialysis
FDA labels Outset Medical recall of Tablo hemodialysis system as Class I
The FDA today labeled Outset Medical’s recall of some Tablo hemodialysis devices as Class I, the most serious kind. The news comes only weeks after analysts expressed optimism that the company was moving ahead of previous regulatory challenges with the FDA. Outset Medical recalled certain Tablo hemodialysis systems after non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching […]
Outset Medical inks deal to expand home hemodialysis in the U.S.
Outset Medical announced today that it partnered with U.S. Renal Care to accelerate home hemodialysis in the U.S. The company entered into a multi-year agreement with U.S. Renal Care, the country’s largest privately held kidney care provider. They aim to utilize the Outset Tablo hemodialysis system as a home dialysis option in the 33 states […]
Outset Medical stock soars on optimistic analyst outlook
Outset Medical shares are on the rise after BTIG analysts initiated coverage with a “Buy” rating for the home hemodialysis company. Shares of OM rose by more than 25% to $2.58 apiece in late-afternoon trading today. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose slightly. The optimistic outlook […]
Baxter in talks over Kidney Care sale, expects separation later this year
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 […]
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 […]