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Corvia Medical’s Corvia atrial shunt did not improve rates of cardiovascular death or non-fatal ischemic stroke after 12 months, or the rate of total heart failure events up to 24 months, in a late-stage trial reported in The Lancet. Read More
The FDA has designated BioCardia’s CardiAMP Cell Therapy System for heart failure a breakthrough device, making it the first combination cardiac cell therapy and device to receive this status. Read More
The agency is hoping for useful feedback from sponsors, researchers, investigators, trial participants, product manufacturers, healthcare professionals and the general public. Read More
A computer algorithm that uses retinal images was able to predict heart attacks with a 74 percent specificity, a team of researchers in the UK have reported. Read More
Cerus Endovascular’s Contour system met safety and efficacy endpoints in an early-stage study for treatment of intracranial aneurysms, according to German researchers. Read More
A hybrid closed-loop insulin delivery system run by a wireless phone app significantly improved glycemic control in a group of very young children with Type 1 diabetes, according to a new study in the New England Journal of Medicine. Read More
Bluestar Genomics’ cell-free DNA blood test identified pancreatic cancer in patients with newly diagnosed diabetes with sensitivity outcomes in the 50 percent range and specificity in the high 90s. Read More
New Britain, Pa.-based Thrombolex said its endovascular-thrombolytic delivery system cleared 90 percent of totally occluded pulmonary arteries in an interim analysis from a pivotal trial. Read More
Sweden’s Xvivo touted the success of its heart perfusion device used in the first successful transplantation of a genetically modified pig heart to a human. Read More
Alpha Tau Medical said its alpha-radiation cancer therapy device Alpha DaRT produced complete tumor responses in all 10 patients treated in a multi-center U.S. trial. Read More