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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It's problematic that the FDA’s recently released device software draft guidance lacked input from the Center for Drug Evaluation and Research (CDER), two industry groups said in written comments to the agency.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
The UK’s National Institute for Health and Care Excellence (NICE) has recommended several diagnostic devices for use in biopsies for suspected prostate cancer. Read More
One of the most confusing issues medical device manufacturers face when servicing their products is determining when a service issue qualifies as a complaint and whether the event must be reported to the FDA. Read More
St. Paul, Minn.-based Minnetronix Medical has teamed up with Canada’s INO Innovation Center to fast-track the process of bringing optical medical devices to market. Read More
The White House Office of Management and Budget (OMB) signed off late last week on the FDA’s proposed rule to harmonize its Quality System Regulation (QSR) with the International Organization for Standardization (ISO) 13485. Read More