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In a 30-patient multicenter retrospective analysis of the device’s use, 97 percent of patients showed an increase in vessel opening of at least 25 percent, with 80 percent of patients showing an increase of 50 percent or more. Read More
An international investigational trial of India-based Sahajanand Medical Technologies’ self-expanding transcatheter aortic heart valve (THF) system, Hydra, showed the implanted system performed well after one year. Read More
A late-stage trial of BioCardia’s CardiAMP cell therapy system for heart failure has passed a milestone, with the independent data safety monitoring board recommending that the study continue as designed. Read More
Patients using Boston, Mass.-based Myomo’s MyoPro powered arm and hand brace showed statistically significant improvements in motor function in a pilot study, according to new research published in the journal Frontiers in Neurology. Read More
It's problematic that the FDA’s recently released device software draft guidance lacked input from the Center for Drug Evaluation and Research (CDER), two industry groups said in written comments to the agency. Read More