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It's problematic that the FDA’s recently released device software draft guidance lacked input from the Center for Drug Evaluation and Research (CDER), two industry groups said in written comments to the agency.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
Despite the reported problems, the agency said that women who have been using Essure successfully to prevent pregnancy “can and should continue to do so.” 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
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 FDA doesn’t want any part of regulating the “sanitation tunnels” that have popped up in certain commercial settings as a response to the COVID-19 pandemic. Read More