UPDATED Sept. 17, 2018, with comment from Haemonetics. The French government reportedly decided on a precautionary suspension of the use of a blood collection device made by Haemonetics (NYSE:HAE) – used in half of all donations there – after receiving numerous reports of problems with the devices. Apheresis devices are used to separate plasma from blood […]
Magnolia Medical launches Sterpaith Gen2 system
Magnolia Medical Technologies said yesterday it launched its Steripath Gen2 blood collection system. The next-generation device features mechanical initial specimen diversion and improved usability based on input from end users, the Seattle-based company said. “Our team is very pleased with the 83 percent reduction in blood culture contamination we have achieved using Steripath. Based on this […]
Outset Medical closes $132m Series D funding round
Outset Medical said today it raised $132 million in a Series D round of equity financing, with funds slated to accelerate the commercial expansion of its Tablo hemodialysis system. The San Jose, Calif.-based company develops and produces the Tablo hemodialysis system, an all-in-1 dialysis machine designed to handle water purification and dialysate production and be […]
Feds give CytoSorbents’ blood filter a shot at $3 million
CytoSorbents (NASDAQ: CTSO) said it has won another round of funding from the U.S. government to commercialize its HemoDefend red blood cell (RBC) transfusion filter. The critical-care immunotherapy company, based in Monmouth Junction, N.J., specializes in blood purification. The National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health, granted the three-year, Phase IIB […]
Magnolia Medical, Kurin trade lawsuits
Magnolia Medical Technologies said yesterday it filed a lawsuit against blood-culture-focused device developer Kurin claiming the company “mischaracterized its clinical data as well as the functionality and ease of use of its device.” The suit comes in response to a similar suit filed by Kurin in the Southern District of California in May which claimed […]
FDA grants DoD approval for freeze-dried plasma on the battlefield
The FDA said today it granted an emergency use authorization to the US Department of Defense for the use of particular freeze-dried plasma products designed for the treatment of hemorrhage or coagulopathy. The approval specifically covers the use of pathogen-reduced leukocyte-depleted freeze-dried plasma produced by the Centre de Transfusion Sanguine des Armées, known in the […]
FDA approves ReCor Medical’s pivotal ultrasound denervation study
ReCor Medical said this week that the FDA approved a new pivotal study of the company’s Paradise ultrasound denervation system for the treatment of hypertension. The Palo Alto, Calif.-based company reported that its trial, Radiance-II, will be a randomized, sham-controlled study in patients with moderate hypertension. The study is designed to demonstrate the Paradise system’s […]
Haemonetics closes $700m debt refi
Haemonetics (NYSE:HAE) said today that it closed the refinancing of some $700 million in debt as part of its restructuring plan. Last November the Braintree, Mass.-based blood management company unveiled plans to cut roughly 11% of its global workforce as it looked to pare $80 million from its annual cash burn by the end of fiscal 2020. […]
Roche launches CoaguCheck Vantus blood coagulation monitor
Roche (OTC:RHHBY) said today it is launching its CoaguCheck Vantus system designed for monitoring blood coagulation, specifically for patients on warfarin therapy. The Switzerland-based company said the CoaguCheck Vantus features built in Bluetooth technology to allow patients to use their smart devices and a compatible application to send results of the coagulation testing to their healthcare […]
Fresenius Medical Care, Humacyte ink $150m strategic partnership deal
Fresenius Medical Care (NYSE:FMS; ETR:FRE) said today it inked a $150 million strategic partnership deal with Humacyte through which Fresenius will gain exclusive rights to commercialize Humacyte’s Humacyl bioengineered blood vessel technology. Research Triangle Park, N.C.-based Humacyte is exploring the use of its Humacyl human acellular vessel as a conduit for hemodialysis in patients with end-stage renal […]
Baxter touts Theranova HDx dialysis tech study data
Baxter (NYSE:BAX) today released new data from studies exploring expanded hemodialysis with its Theranova dialyzer, touting the device’s ability to clear large middle molecules at a higher rate than standard hemodialysis and equal or faster removal rates compared to high-volume hemodiafiltration. Results from a number of studies and poster presentations on the Theranova dialyzer were presented […]
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