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 […]
Dialysis
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 […]
Laminate Medical lands FDA breakthrough nod for dialysis device
Laminate Medical Technologies today announced it has won FDA breakthrough device designation for its VasQ external support for patients in need of an arteriovenous fistula (AVF) for hemodialysis. Tel Aviv, Israel–based Laminate’s VasQ device is a nitinol external support placed around the artery and vein at the creation site. It is designed to optimize the […]
Merit Medical lands CE mark for Wrapsody endovascular stent graft
Merit Medical (NSDQ:MMSI) announced that it received CE Mark approval in Europe for its Wrapsody endovascular stent graft system. Wrapsody is a flexible, self-expanding endoprosthesis indicated for use in hemodialysis patients for treating stenosis or occlusion within central veins, along with the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft, according to a […]
Cantel Medical pulls in $28m
Cantel Medical (NYSE:CMD) announced today that it sold $28 million in aggregate principal amount of convertible senior notes. The 3.25% convertible senior notes due in 2025 are pursuant to the full exercise by the initial purchasers of their option to purchase additional notes. Cantel Medical has issued a total of $168 million in aggregate principal amount […]
Medtronic wins pediatric blood-filtering device clearance
The FDA yesterday granted de novo clearance to a Medtronic (NYSE:MDT) device designed to provide continuous dialysis in critically ill young children. The Carpediem extracorporeal blood-filtration system was designed to provide continuous renal replacement therapy (CRRT) to critically ill patients weighing 5.5 to 22 lb. These patients must have a sudden or temporary loss of kidney […]
Baxter granted FDA EUA for Oxiris blood purification filter in COVID-19 treatment
Baxter (NYSE:BAX) announced that it received FDA emergency use authorization (EUA) for use of its Oxiris filter in treating COVID-19 patients. The authorization is for the use of Oxiris in patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure that are in need of blood purification therapy to reduce pro-inflammatory cytokine […]