FDAnews Device Daily Bulletin

The FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds.

Brazil is streamlining its good manufacturing practice requirements, replacing RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostics with a single regulation, RDC 16/2013.

The FDA has issued new draft guidance clarifying the process through which device manufacturers can appeal the agency’s rulings on marketing applications.

The U.S. Attorney’s office in Manhattan says that three NYU researchers working on MRI technology conspired to take bribes from Chinese researchers in exchange for providing nonpublic information on their own research.

A new test to detect elephantiasis in human blood has proven to be significantly better than the previous card test.

The U.S. Supreme Court has agreed to take Boston Scientific’s case, accusing Medtronic of infringing on the company’s patents on cardiac resynchronization therapy.

Roche Australia has recalled several of its monitors that test the blood of patients taking anticoagulants.

Researchers have determined that by using radio frequencies directed at medical devices operating on analog sensors, they can then disrupt those devices.