Medtronic (NYSE:MDT) announced today that it launched its Carpediem cardio-renal pediatric dialysis emergency machine in the U.S. Fridley, Minn.-based Medtronic’s Carpediem machine received FDA de novo clearance in May for providing continuous dialysis in critically ill young children. The first-of-its-kind machine is indicated for use in acute kidney injury or fluid-overloaded patients requiring hemodialyiss or hemofiltration […]
Dialysis
Baxter gains FDA clearance for home dialysis system
Baxter (NYSE:BAX) announced today that it received FDA clearance for its Homechoice Claria automated peritoneal dialysis (APD) system with Sharesource. Homechoice Claria is designed to combine its simple user interface with the Sharesource two-way remote patient management platform for patients on peritoneal dialysis, according to a news release. The system is cleared for both adult and […]
Home dialysis gets a boost from Medicare
Medicare will now provide additional coverage for certain home dialysis equipment for patients with chronic kidney failure. The final rule published today encourages the development of new and innovative home dialysis machines. It follows a September announcement of a new model to shift Medicare payments from traditional fee-for-service payments to payments in which providers are incentivized for encouraging the […]
Fresenius wins FDA approval for next-gen dialysis solution bags
Fresenius Medical Care North America (NYSE:FMS) recently announced that FDA has approved its Deleflex peritoneal dialysis solutions bagged in its less wasteful Biofine material. Company officials expect the new Biofine peritoneal solutions bag to be first available to a limited number of patients in the U.S. this fall. “The new Biofine peritoneal dialysis solutions line is […]
Fresenius to enter heart, lung, organ failure markets
Fresenius Medical Care (NYSE:FMS) announced today that its new growth strategy includes treating heart, lung and multi-organ failure. Hamburg, Germany-based Fresenius’ strategy centers around three major areas: renal care, critical care solutions and complementary assets, according to a news release. The company’s renal care continuum is to be bolstered by artificial intelligence and data analysis technologies […]
Medicare to cover more home dialysis
The Centers for Medicare & Medicaid Services (CMS) announced that it finalized an expansion of its care offerings for patients with chronic kidney disease. CMS completed its end-stage renal disease (ESRD) treatment choices (ETC) model for improving or maintaining the qualityof care and reducing Medicare expenditures for patients with chronic kidney disease, impacting approximately 30% […]
DTW Podcast: 3 lessons learned from Leslie Trigg, CEO of Outset Medical
Outset Medical (NSDQ:OM) CEO Leslie Trigg took the helm at the dialysis start-up in 2013, moving from an executive-in-residence post at private equity firm Warburg Pincus. Before that she held senior positions at Lutonix, AccessClosure and FoxHollow, helping to position those companies to be acquired by CR Bard, Cardinal Health, and ev3/Covidien, respectively. This week, […]
Outset Medical IPO raises nearly $278M
Outset Medical (NSDQ:OM) has brought in nearly $278 million from its IPO that closed today, two days after its shares started trading on the Nasdaq. The maker of the Tablo hemodialysis system raised$277.9 million before deducting underwriting discounts and commissions and offering expenses. The nearly 10.3 million OM shares sold at an initial offering price […]
Baxter’s dialysis filter wins De Novo nod
Baxter (NYSE:BAX) announced today that it received FDA De Novo classification for its Theranova novel dialysis membrane. Theranova is designed to deliver expanded hemodialysis (HDx) therapy, filtering a wider range of molecules from the blood than traditional hemodialysis (HD) filters, targeting certain molecules associated with inflammation and cardiovascular disease in patients with kidney failure, according to […]
CMS pushes for return to essential kidney treatments, transplants
The Centers for Medicare & Medicaid Services (CMS) has announced updated guidance urging for the resumption of kidney procedures. CMS said its guidance is designed to ensure medical providers can able return to offering essential surgical, life-sustaining procedures while reinforcing infection control precautions at dialysis facilities in COVID-19 hotspots. The guidance includes a checklist of […]
Baxter gains EUA for renal replacement tech for critically ill children
Baxter (NYSE:BAX) announced today that it received FDA emergency use authorization (EUA) for its HF20 Set and ST Set for continuous renal replacement therapy (CRRT). Under EUA, the HF20 Set can deliver CRRT to treat patients of low weight (8-20 kg) and low blood volume who can’t tolerate a larger extracorporeal circuit volume in an acute […]
