CytoSorbents (OTC:CTSO) said this week it the Data Safety Monitoring Board of its REMOVE trial gave the company the green light to continue the study after analyzing data from the first 50 patients. The German gov’t-funded randomized, controlled, multi-center 250-patient REMOVE trial, which was launched in late 2017, looked to explore the safety and efficacy of […]
Blood Management
Magnolia Medical closes $20m Series C
Magnolia Medical Technologies said today that it closed a $20 million Series C financing round slated to help grow the company’s infrastructure and market initiatives to meet demand for its Steripath Gen2 initial specimen diversion device. The next-generation device, launched last August, features mechanical initial specimen diversion and improved usability based on input from end […]
Abbott inks deal to test blood donations in Japan
Abbott (NYSE:ABT) said today that it has been selected by the Japanese Red Cross Society (JRC) to partner in screening the country’s blood donations. The eight-year contract is for the exclusive supply of serological instrumentation, tests, and consumables used for blood and plasma screening. The JRC screens approximately 5 million blood donations each year, helping ensure a […]
RFPi wins FDA nod for non-contact blood flow imaging tech
FDA has cleared RFPi’s iCertainty real-time, noninvasive blood flow and perfusion imaging medical device for use during surgical procedures, the company said. iCertainty is the first medical imaging device to show blood flow without interrupting a surgical procedure or requiring injections, dyes, radiation or direct patient contact, according to the Greenville, N.C. company. Use of iCertainty during surgery could reduce […]
Awak Technologies wins FDA breakthrough designation for portable PD device
Awak Technologies said today that it won a breakthrough device designation from the FDA for its wearable Awak Peritoneal Dialysis system. The Awak PD system is a portable, wearable peritoneal dialysis system which allows dialysis to be performed “on-the-go”, the Singapore-based company said. The breakthrough designation was granted based on results from the first-in-human safety […]
Cerus launches U.S. pivotal, bids for CE Mark for Intercept red blood cell treatment
Cerus Corp. (NSDQ: CERS) this week launched a U.S. pivotal trial and filed for CE Mark approval in the European Union for its Intercept red blood cell treatment. The 600-patient Recipi study is a randomized, double-blinded, controlled, parallel group, non-inferiority, Phase III trial designed to gauge the safety and efficacy of Intercept. Subjects undergoing transfusion for acute blood […]
Vetex Medical launches first-in-human thrombectomy cath trial
Vascular device developer Vetex Medical said today that it launched a first-in-human trial of its Vetex thrombectomy catheter intended for treating deep vein thrombosis and that the first patient in the trial has been treated in the study. The Galway, Ireland-based company said that the Vetex cath uses both rotational and grasping action during the […]
J&J’s Cerenovus launches global thrombectomy registry
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today that it launched a new registry aiming to collect and analyze stroke-inducing blood clots removed with the company’s Embotrap II revascularization device. The Irvine, Calif.-based company touted the Excellent registry as the single largest global registry of its kind to date, looking to enroll up to 1,000 ischemic stroke patients […]
Edwards wins FDA nod for next-gen HemoSphere platform
Edwards Lifesciences (NYSE:EW) said yesterday that it won FDA 510(k) clearance for its Hemosphere platform with the Acumen suite of decision-support solutions intended for hemodynamic monitoring. The Irvine, Calif.-based company touted that the newly cleared HemoSphere platform is the first to include predictive monitoring for moderate to high-risk surgical patients. The system now includes the […]
Avenu Medical wins CMS reimbursement for Ellipsys dialysis device
Vascular access system maker Avenu Medical said last Friday it won a HCPCS C-Code from the Centers for Medicare and Medicaid Services for its Ellipsys dialysis device and the endoAVF procedure. The San Juan Capistrano, Calif.-based company’s Ellipsys vascular access system device is designed for use with end-stage renal disease patients who require hemodialysis. The system, which […]
Baxter touts Hemopatch, Floseal study results
Baxter (NYSE:BAX) today presented results from studies of its Hemopatch and Floseal products, touting reductions in costs and hospital stays in both trials. Results from studies of the devices were presented this week at the International Society for Pharmacoeconomics and Outcomes Research Europe 2018 meeting, the Chicago-based company said. In a retrospective observational analysis exploring pancreaticoduodenectomies […]