This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...
In 2012 The Wall Street Journal published a story that quoted a big medical device company spokesperson explaining that they couldn't provide patients the medical device data gathered by implanted ...
In August, the Food and Drug Administration published a guidance recommending hospitals move away from using Hospira’s Symbiq Infusion System, a computerized pump designed for continuous infusion ...
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