The Food and Drug Administration is investigating how a contracted document management company accidentally made public 75,000 pages of confidential FDA files related to approval of medical devices, ...

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 ...

Almost 83,000 people have died around the world, including 170 in Australia in the past decade, due to potentially dangerous medical devices, an international investigation into the global device ...

Defective medical devices — and the lack of laws or enforcement against them — have killed thousands of patients around the world and put millions more at risk. Yet, in my country and many others, few ...

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 ...