Neuravi said today it raised $16.7 million (EU €15 million) in a new round of debt financing, with funds slated to support U.S. commercialization and portfolio expansion. Money in the round came from healthcare alternative financing provider IPF Partners, the Galway, Ireland-based company said. Funds raised in the round will be invested into the U.S. commercialization […]
Blood Management
Johnson & Johnson’s Ethicon wins FDA nod for expanded Evarrest indication
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it won an expanded indication from the FDA for its Evarrest fibrin sealant patch, now cleared for use as an adjunctive hemostat across a “broad range” of challenging patient types and surgical situations. The company touted the win as a significant milestone in controlling problematic bleeding situations “with high confidence.” “I’m […]
Baxter launches Theranova dialyzer in Europe, Down Under
Baxter (NYSE:BAX) said today it launching its novel Theranova HDx hemodialysis therapy system in Australia, New Zealand, France, Germany, Switzerland and Belgium. The device operates around the company’s new Theranova dialyzer designed to extend the range of molecules that it filters from the blood, claiming it “more closely mimics the natural kidney.” ”Through HDx enabled by […]
Vascular Solutions bids for FDA nod for RePlas freeze-dried plasma
Vascular Solutions (NSDQ:VASC) said today that it filed an investigational new drug application with the FDA for the RePlas freeze-dried plasma product it’s developing with the U.S. Army Medical Material Development Activity. RePlas is an easily transported, freeze-dried alternative to fresh frozen plasma, which requires freezing and a lengthy thawing process before it’s ready to use. According to the development […]
Fresenius Kabi wins FDA nod for Aurora Xi plasmapheresis system
Fresenius Kabi (NYSE:FMS) said today that it won FDA 510(k) clearance for its Aurora Xi plasmapheresis system. Plasma, a component of blood that contains proteins, is used in therapies to treat burn victims, bleeding disorders, and other chronic and genetic problems. Patients who require plasma infusions or injections have to get them regularly and often […]
NxStage inks home hemodialysis deal with Satellite Health
NxStage Medical (NSDQ:NXTM) said today it inked a 3-year home hemodialysis supply agreement with Satellite Healthcare. Satellite, a non-profit group, is the 6th-largest dialysis and kidney disease treatment provider in the U.S. The deal will put NxStage’s Nx2me connected health platform in the hands of Satellite’s home hemodialysis patients. “We’re delighted that our depth of experience and […]
Edwards Lifesciences wins CE Mark for Acumen hypotension monitor
Edwards Lifesciences (NYSE:EW) said today that it won CE Mark approval in the European Union for its Acumen hypotension probability indicator. The newly cleared Acumen monitor is designed to alert clinicians to potential hypotension, defined as abnormally low blood pressure, for surgical and critical care patients, the Irvine, Calif.-based company said. “Studies have shown that even […]
Becton Dickinson wins 510(k) for Vacutainer Barricor tubes
Becton Dickinson & Co. (NYSE:BDX) said today it won FDA 510(k) clearance for its Vacutainer Barricor plasma blood collection tube. The Franklin Lakes, N.J.-based company touted improvements to the next-gen blood collection and separation device, saying its designed to improve sample quality, speed up result returns and improve patient care and clinical efficiency. “As we launch […]
Phenox touts pREset thrombectomy device trial data
German device maker Phenox today released data from a study of its pREset thrombectomy device, touting high rates of positive clinical outcomes and freedom from severe neurological deficits. The 100-patient trial examined a total of 109 acute intracranial vessel occlusions treated with the pREset device, looking to evaluate the efficacy of the device, overall safety […]
CytoSorbents enters Iran
CytoSorbents said today that it’s entering the Iranian market with its CytoSorb adsorber through an exclusive distribution agreement with Armaghan Salamat Kish Group. CytoSorb is designed to reduce excessive levels of inflammatory mediators in cardiac surgery and critically ill patients, the Monmouth Junction, N.J.-based company said. “We are pleased that Armaghan Salamat Kish will be working with us to […]
Terumo, CytoSorbents ink cardiac surgery deal
Terumo Corp. (TYO:4543) said today it inked a strategic partnership deal with CytoSorbents to commercialize its CytoSorb blood purification adsorber for cardiac surgery applications. New Jersey-based CytoSorbents said its CytoSorb adsorber is designed to reduce excessive levels of inflammatory mediators in cardiac surgery and critically ill patients. “Our collaboration with CytoSorbents enables us to offer […]