SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections. The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff […]
Dialysis
Outset Medical stock down on shipment hold news
Outset Medical (Nasdaq: OM) stock lost about a third of its value today — a day after the company said it was holding shipments of its Tablo hemodialysis system for home use. OM shares were down more than 34% to $13.46 apiece by the close of trading today. MassDevice‘s MedTech 100 Index, which includes stocks of […]
Medtronic, DaVita to form new kidney care company
Medtronic (NYSE:MDT) and DaVita (NYSE:DVA) today announced the intent to form a new medical device company for kidney care. The new, independent company — dubbed “NewCo” for now — aims to enhance the patient treatment experience and improve overall outcomes for kidney care patients. According to a news release, the new company will bring together […]
Device developer SeaStar Medical hires chief medical officer
SeaStar Medical has hired Dr. Kevin Chung as chief medical officer of the medtech developer starting July 1. Denver-based SeaStar is developing a platform therapy focused on hyperinflammation of vital organs. The company’s Selective Cytopheretic Device was designated as a breakthrough device by the FDA earlier this year. SeaStar is set to go public in the […]
FDA warns of potential toxic risk from Fresenius hemodialysis machines
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 […]
Fresenius Medical Care hires replacement for longtime CEO
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 […]
Baxter posts Street-beating Q1 results, cites ‘positive momentum’ from Hillrom acquisition
Baxter (NYSE:BAX) this week posted first-quarter results that beat the overall consensus on Wall Street. The Deerfield, Illinois-based maker of products to kidney disease — and a host of other chronic and acute medical conditions — reported profits of $71 million, or 14¢ per share, on sales of $3.7 billion for the three months ended […]
FDA clears Fresenius’ next-gen portable automated peritoneal dialysis system
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 […]
Fresenius enters 3-way merger to create independent kidney care provider
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 […]
Medtech Color names 10 finalists in 2022 Pitch Competition
Medtech Color recently announced the top 10 finalists for its 2022 Pitch Competition. The Medtech Color 2022 Pitch Competition is a foundational start for medical technology, early-stage startups creating innovative technologies. It focuses on startups led by Black and Brown founders to showcase products and services that directly benefit patients. Get the full story on […]
Outset Medical rises on Street-beating Q4 revenues, high growth projections for 2022
Outset Medical (NASDAQ:OM) shares shot up today on fourth-quarter revenues that beat the consensus forecast. OM shares were up more than 16% at $39.77 per share by late afternoon trading today. MassDevice’s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down 1.6%. The San Jose, California-based dialysis technology developer posted […]
