CytoSorbents (OTC:CTSO) announced that it received FDA breakthrough device designation for its CytoSorb blood purification technology for use during emergent and urgent cardiothoracic surgery. Monmouth Junction, N.J.-based CytoSorbents designed its CytoSorb technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients. The FDA breakthrough nod is for the use of CytoSorb for […]
FDA grants EUA for CytoSorb blood purification technology
CytoSorbents (OTC:CTSO) announced today that it received FDA emergency use authorization (EUA) for use of its CytoSorb blood purification technology in COVID-19 patients. With the authorization, Monmouth Junction, N.J.-based CytoSorbants is entitled to make CytoSorb commercially available to all U.S. hospitals for coronavirus patients aged 18 and older who are admitted to the intensive care unit […]
COVID-19 test development surges with pandemic
Companies around the world are racing to develop and distribute tests for COVID-19 to laboratories and to market other products and services they say can help patients and healthcare providers cope with the pandemic. On March 13, the FDA gave Thermo Fisher Scientific (NYSE:TMO) emergency use authorization (EUA) for a diagnostic test that certain U.S. laboratories […]
Safety board OKs continuation of CytoSorbents endocarditis trial
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 […]
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 […]
Could this system make more kidneys, livers usable for transplant?
An Italian startup has teamed with critical-care immunotherapy company CytoSorbents Corporation (NASDAQ: CTSO) on an integrated ex-vivo system to perfuse, cleanse, recondition and preserve harvested kidneys and livers — including those that are usually discarded. Aferetica srl (Mirandola, Italy) designed its PerLife system is to improve organ function and viability while reducing the risk of primary graft failure and […]
7 medtech stories we missed this week: June 15, 2018
From Cytosorbents opening a new U.S. manufacturing facility to DyAnsys received FDA clearance for a wearable to treat opioid withdrawals, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Cytosorbents opens new U.S. manufacturing facility CytoSorbents announced in a June 12 press release that it has opened a new […]
CytoSorbents wins German gov’t funding for CytoSorb endocarditis trial
CytoSorbents (OTC:CTSO) said this week it won funding from the German Federal Ministry of Education and Research for a randomized controlled trial exploring the use of its CytoSorb blood purification technology for treating infective endocarditis. The newly funded randomized, controlled, multi-center Remove trial aims to enroll 250 patients to explore the safety and efficacy of intraoperative […]
DJO Global names new surgical prez | Personnel Moves – June 1, 2017
DJO Global said this week that it hired Jeffery McCaully as global president of its surgical business, effectively immediately. McCaulley succeeded Brady Shirley, who was named DJO’s president & CEO in November last year. McCaulley previously served as president & CEO of Smiths Medical, as well as president of Zimmer Biomet‘s (NYSE:ZBH) global reconstructive unit, where […]
CytoSorbents touts Refresh trial study data
CytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery. Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week. The Monmouth Junction, N.J.-based company’s CytoSorb […]
CytoSorbents shares lift on Q4 prelims
CytoSorbents Corp. (NSDQ:CTSO) posted its preliminary financial results for the 4th quarter, meeting analysts’ expectations on Wall Street. The Monmouth Junction, N.C.-based company said it expects a total revenue of $2.6 million for Q4, up 73% from $1.5 million in the same quarter in 2015 and up 20% from the 3rd quarter of 2016. Analysts on […]
