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When analyzing potential trends in complaints, devicemakers must establish three parameters to monitor: the time interval for analysis; the number of events in the time interval; and product volume in the market. 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
More than half of internet-connected medical devices in hospitals “have a known critical vulnerability,” but intravenous (IV) pumps are at the top of the list, says health tech company Cynerio. Read More
The European Parliament has endorsed a plan to strengthen the powers of the European Medicines Agency (EMA) to increase monitoring of the supply chain for drugs and medical devices. Read More