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The platform showed a sensitivity of more than 98 percent in finding the extent of cancer in patients who have intermediate-risk disease — the most frequently treated form of prostate cancer. Read More
Smiths Medical has issued an urgent medical device correction letter to customers warning that its CADD (computerized ambulatory delivery device) infusion sets for use with CADD pumps could fail to deliver an infusion or could set off a false alarm. Read More
The EU is considering a proposal to delay by several years the compliance deadline for its Medical Device Regulation (MDR) which was to go into effect May 26, 2024, as there are insufficient resources to meet the deadline required by law. Read More
An FDA inspection of Prime Lab USA’s facility in Miami, Fla., landed the company a Form 483 for inadequately storing product, evaluating suppliers and handling customer complaints, among other lapses.
The FDA explores the blurred regulatory line between medical device software and non-device software functions in a new report that concludes the benefits of non-device software outweigh the risks.
In a nod to the increasing development of three-dimensional visualization tools, the FDA has created a new page on its website devoted to listing augmented and virtual reality medical devices.