Fist Assist Devices recently announced that it received CE Mark approval for its Fist Assist device for vein enhancement and enlargement. Los Altos Hills, Calif.-based Fist Assist Devices said it has begun commercialization and marketing of the device in the European Union. The Fist Assist device is a non-invasive external platform designed to utilize a […]
CloudCath raises $12m for at-home dialysis monitoring software
CloudCath announced today that it completed a $12 million Series A financing round for its at-home dialysis monitoring treatment platform. San Francisco–based CloudCath’s system, which is its first product, is designed to enable remote, real-time monitoring for people undergoing at-home peritoneal dialysis to allow for earlier complication intervention. Proceeds from the funding round are also […]
Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter
Bluegrass Vascular Technologies announced that it won FDA de novo clearance for its Surfacer inside-out access catheter system. The Surfacer is designed to obtain central venous access through its inside-out approach, facilitating catheter insertion to the central venous system in people with upper body venous occlusions or other conditions that limit central venous access through […]
Outset Medical raises $125m for its all-in-one dialysis system
Outset Medical has raised $125 million in a Series E equity financing round that will help support the commercial expansion of the Tablo hemodialysis system in the U.S. D1 Capital Partners led the round, with Fidelity Management and Research C., Partner Fund Management, Perceptive Advisors, and funds advised by T. Rowe Price Associates also participating. […]
Laminate Medical completes enrollment in U.S. pivotal trial
Laminate Medical Technologies announced that it completed enrollment into its VasQ external support U.S. pivotal study of patients in need of an arteriovenous fistula (AVF) for hemodialysis. The study prospectively enrolled 144 male and female patients, both brachiocephalic and radiocephalic AVF patients, across 17 sites in the U.S. They are slated to be followed for […]
B. Braun Medical names new chairman & CEO
B. Braun Medical has announced that Jean-Claude Dubacher will succeed longtime company leader Carroll Neubauer as chairman and CEO on Jan. 1, 2020. Neubauer will stay on as chairman and CEO of B. Braun of America, which owns B. Braun Medical (Bethlehem, Pa.), admixture pharmaceutical firm CAPS, Aesculap and B.Braun Interventional Systems. He has been […]
Awak Technologies raises $40m
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 […]
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