Merit Medical (NSDQ:MMSI) systems announced that it won two additional breakthrough device designations from the FDA for its Wrapsody endovascular stent graft system. Wrapsody is designed as a flexible, self-expanding endoprosthesis and won a breakthrough nod in November 2019 for hemodialysis treatment. Its latest indications include treating stenosis or occlusion within the dialysis outflow circuit, including […]
Dialysis
Outset Medical at-home dialysis system wins FDA approval
Outset Medical announced that it won expanded FDA clearance for patient use in the home with its Tablo hemodialysis system. Tablo’s existing indication included use in acute and chronic care facilities but, amid the COVID-19 pandemic, can now offer hemodialysis treatment from the home as in-hospital treatment is more of a challenge under current circumstances. […]
Fist Assist announces CE Mark and European launch
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 […]