FDA clears a Sky Medical Technology 510(k) for its geko device for stimulation of the calf muscles to prevent venous thrombosis in non-surgical patien...
FDA releases a dashboard to help view data on Biosimilar User Fee Act performance metrics.
Federal Register notice: FDA makes available a final guidance on coronary, peripheral, and neurovascular guidewire testing and labeling.
Federal Register notice: FDA makes available a final guidance entitled Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission...
FDA grants a de novo clearance for OraSure Technologiess OraQuick Ebola Rapid Antigen Test to detect Ebola virus antigens in human blood from certain ...
Four stakeholders comment on an FDA draft guidance on its inactive ingredient database.
The Justice Department says UTC Laboratories and its three principals will pay $42.6 million to resolve six whistleblower False Claims Act suits.
ICU Medical recalls certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for fluid leaks.