The Food and Drug Administration is rolling out a handful of new guidelines aimed at fostering medical device innovation by allowing manufacturers to make small iterative modifications to their ...

The Food and Drug Administration is investigating how a document-management company inadvertently made public some 75,000 pages of confidential agency files about the approval of medical devices, FDA ...

As a soldier, Wolfgang Neszpor spent a decade serving his country. But he never expected his most serious injury to come when he was safely back home in Brisbane. The US-made shoulder implant has not ...