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The problem could cause serious adverse events, such as a tear along the inside wall of an artery, or other complications that could require surgical repair, the agency said. 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
The FDA has extended its delay on conducting in-person domestic surveillance in-spections through Feb. 4 with the goal of restarting the activities as soon as safely pos-sible. Read More
In responses to two Republican senators, Robert Califf — the Biden administration’s nominee for FDA commissioner — provided a deeper look into the priorities he would set at the helm of the agency if confirmed to the top post once again. Read More
SoftSmile is currently working with several aligner manufacturers, but will now start marketing Vision as a standalone application to be used directly by doctors. Read More