Fresenius Medical Care (NYSE:FMS; ETR:FRE) agreed to pay more than $5 million to resolve allegations that its dialysis clinic business over-billed Medicare for hepatitis B tests. The country’s largest dialysis clinic operator, Fresenius Medical Care North America agreed to pay $5.2 million to settle federal prosecutors’ allegations that it billed Medicare for tests of dialysis patients […]
Outset Medical wins HHS contract for Tablo home dialysis device
Outset Medical said today that it won a contract from the U.S. Health & Human Services Dept. for using its Tablo hemodialysis systems in response to natural disasters. Tablo is designed to use wireless data, sensor-based automation and an animated touchscreen to make dialysis care accessible in-home, requiring only an electrical outlet and tap water […]
Baxter touts Sharesource home dialysis study
Baxter (NYSE:BAX) said today that patients treated with automated peritoneal dialysis cyclers and its Sharesource remote patient management platform showed significant reductions in hospitalization rates and hospitalization days. The results of a study comparing peritoneal dialysis patients managed with Sharesource to those not using the remote platform at home showed a 39% reduction in hospitalizations for […]
Medtronic’s In.Pact AV DCB meets endpoints in trial
Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints. The study pitted the In.Pact AV DCB against PTA in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. Results were presented at the Cardiovascular and Interventional Radiology Society […]
Fresenius recalls dialysis tubes due to dangerous, undetectable leaks
Fresenius Medical Care (NYSE:FMS; ETR:FRE) last week recalled two sets of its bloodlines due to potentially deadly leaks in the tubes. Germany-based Fresenius said that two sets of its 4008 bloodlines (AV-Set B-R F00001124 and AV-Set SRB-R F00000257) containing a total of 25 batches experienced tube rupture that led to blood leakage. A dialysis machine cannot […]
Concept Medical wins FDA breakthrough nod for MagicTouch AVF drug-coated balloon
Concept Medical said yesterday that it won breakthrough designation from the FDA for its MagicTouch AVF drug-coated balloon. MagicTouch AVF is designed to treat stenotic lesions of arteriovenous fistulae or arteriovenous graft in hemodialysis treatment of renal failure. India-based Concept Medical’s device is indicated for use in percutaneous transluminal angioplasty. The PTA procedure, using Concept […]
Surmodics reaps $10m from Abbott on SurVeil balloon milestone
Surmodics (NSDQ:SRDX) said today that it’s due for a $10 million milestone payment from Abbott (NYSE:ABT) after closing enrollment for the Transcend pivotal trial of its SurVeil drug-coated balloon for treating peripheral artery disease. Abbott in February 2018 paid $25 million up front for the global commercialization rights to the SurVeil device, which uses a proprietary […]
Baxter throws $500m behind CMS push for dialysis innovation
Baxter (NYSE:BAX) officials apparently think their company can benefit from a Trump administration and CMS proposal to provide extra reimbursement for new and innovative dialysis equipment and supplies. Just days ago, CEO Joe Almeida told analysts in an earnings call that the company planned to invest $500 million to significantly increase production capacity and meet new […]
Quanta Dialysis Technologies raises $48m
Quanta Dialysis Technologies (Alcester, U.K.) said today that it has closed on a £38 million ($48 million) Series C funding round. The money will support the British commercial launch of the company’s SC+ personal hemodialysis system as well as a 510(k) clearance submission to U.S. FDA later this year. The SC+, which received a CE […]
CVS launches trial for HemoCare home dialysis device
CVS Health (NYSE:CVS) launched a clinical trial of the home hemodialysis device it developed in conjunction with Dean Kamen’s Deka Research & Development, aiming to capitalize on the federal government’s plan to overhaul the way kidney disease is treated in the U.S. CVS said the 70-patient study is designed to evaluate the safety and efficacy of […]
Trump reveals plan to overhaul kidney disease care
The Trump administration yesterday revealed its plan to overhaul the way kidney disease is treated in the U.S., looking to increase early detection and emphasize transplants and home hemodialysis instead of in-clinic treatment via executive order. Shares of dialysis providers DaVita Healthcare (NYSE:DVA) and Fresenius (NYSE:FMS) took a hit earlier this week on news of the changes. The executive […]
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