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Devices and replacement parts that are “printed” using new three-dimensional printing technologies must meet the same quality benchmarks as traditionally manufactured devices, trade groups emphasized in written comments to the FDA. Read More
Therma Bright said it is “the first company in the COVID-19 diagnostic testing space to successfully complete a 15-minute rapid antigen saliva-based U.S. study.” Read More
NPseal delivers the same type of negative pressure wound therapy as the currently available, more expensive and complex devices, the company said. Read More
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