Awak Technologies announced today that it raised $40 million in an oversubscribed financing round as it readies its Awak PD (peritoneal dialysis) device. Singapore-based Awak said the latest funding is earmarked for late-stage clinical studies and commercialization acceleration for the portable, wearable PD device that does not require medical supervision when administered. The device is […]
Merit Medical lands breakthrough designation for dialysis stent graft system
Merit Medical (NSDQ:MMSI) announced last week that it has been granted FDA breakthrough device designation for its Wrapsody endovascular stent graft system. Wrapsody is a flexible, self-expanding endoprosthesis designed for hemodialysis patients. Merit said it will seek indication to treat stenosis within the central veins of the outflow circuit of an arteriovenous fistula (AVF) up […]
FDA approves Medtronic balloon to treat lesions hindering dialysis
Medtronic (NYSE:MDT) has secured FDA approval for its IN.PACT AV paclitaxel-coated balloon, meant to treat reoccurring blood vessel narrowing that delays people with end-stage renal disease from receiving needed dialysis. “In many cases, AV fistula are considered lifelines for patients with [end-stage renal disease] as they are the primary access point for life-saving dialysis treatment. When […]
Baxter, Ayogo launch digital education tool for kidney disease patients
Baxter (NYSE:BAX) and Ayogo Health Inc. announced today that they are launching the pilot of CKD&Me, a smartphone app that tailors educational content to chronic kidney disease patients’ learning needs, in several nephrology practices across the U.S. CKD&Me is designed to supplement education programs provided by nephrologists and their teams by offering pre-dialysis education for patients […]
Fresenius Medical Care North America launches connected health platform
Fresenius (NYSE:FMS) recently announced that its Fresenius Medical Care North America (FMCNA) business has launched a connected health platform called TheHub. TheHub includes three integrated applications meant to enable people on dialysis, their care teams, and health providers to better collaborate. Fresenius officials see the system enhancing remote monitoring for people on home dialysis. The Trump administration […]
Fresenius Medical Care wins FDA breakthrough nod for clot-preventing dialysis device
Fresenius Medical Care North America (NYSE:FMS) said today that it won breakthrough device designation from the FDA for the new hemodialysis system it’s developing. Waltham, Mass.-based Fresenius said its Endexo antithrombogenic additive is being incorporated into the manufacturing of dialyzers and bloodlines. The device is a polymer made of modifying molecules designed to inhibit the adsorption […]
Report: Fresenius to shutter Ohio billing operation, lay off 57
Fresenius Management Services (NYSE:FMS; ETR:FRE) is reportedly closing its medical billing facility and laying off nearly 60 employees in North Olmsted, Ohio. The company filed a Worker Adjustment and Retraining Notification on Oct. 4 saying that it would lay off 56 employees on December 6 and add one more employee to the layoffs on Jan. […]
Fresenius settles Medicare over-billing case for $5m
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 […]
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