Medtronic attorney Max Heerman says company representatives provide valuable assistance in operating rooms and should continue to be welcomed there wi...
FDA warns users of Medtronics NavLock Tracker device not to use non-Medtronic surgical stereotaxic navigation instruments due to the potential for inc...
FDA gets a $39 million boost in its fiscal year 2017 spending under a budget bill lawmakers unveiled Monday.
Federal Register notice: FDA announces that two information collection proposals on establishment registration have been approved by the Office of Man...
FDA clears a Roche 510(k) for its cobas e 801 module for use on the cobas 8000 modular analyzer system.
FDA clears a Coapt 510(k) for its Complete Control System, an intuitive device for controlling advanced prosthetic arms.
Sanofi and Regeneron Pharmaceuticals resubmit their BLA for sarilumab, an investigational interleukin-6 receptor antibody for treating adult patients ...
Federal Register notice: FDA announces the availability to license an agency invention for Solid-Phase Purification of Synthetic DNA Sequences.