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 […]
Dialysis
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 […]
The top 5 MassDevice stories of the week — July 31, 2020
The past week has seen a slew of Q2 earnings reports from medical device companies — and the picture overall hasn’t been pretty amid the COVID-19 pandemic. Still, medtech CEOs during their earnings calls said they’re starting to see some signs of hospital procedures recovering a bit even as the southern U.S. deals with a […]
Baxter, Ayogo to provide digital health support for people with kidney failure
Baxter (NYSE:BAX) and Ayogo Health Inc. announced today that they are expanding their partnership to support people with kidney disease. The partnership between Deerfield, Ill.-based Baxter and Vancouver, B.C.-based Ayogo will combine the latter’s LifePlan behavior-based digital platform with Baxter’s renal care expertise to build mobile apps and digital solutions to support kidney failure patients, according […]
Baxter systems flagged for cybersecurity vulnerabilities
The U.S. Department of Homeland Security released notices citing cyber vulnerabilities with four devices made by Baxter (NYSE:BAX). Included among the devices listed by DHS were Baxter’s PrismaFlex/PrisMax devices, its ExactaMix, its Phoenix hemodialysis delivery system and its Sigma Spectrum infusion pumps. All four notices included warnings regarding the devices’ Cleartext transmission of sensitive information. According […]
Fresenius Medical Care expands transitional care in the U.S.
Fresenius Medical Care said it is expanding its transitional care units in the U.S. this year. The company plans to open more than 100 new TCUs in 2020 to help people recently diagnosed with kidney failure to learn about the treatment options available, including home dialysis. TCUs are designed as a separate space within a […]
