The FDA grants de novo clearance to HeartFlow's novel system for non-invasive measurement of fractional flow reserve, which CEO Dr. John Stevens calls "the gold standard" for diagnosing and treating coronary disease.
The FDA wants companies that make dermal fillers to treat wrinkles to update their labeling to indicate the risk of injury from unintentional injection into blood vessels.
(Reuters) — The FDA today asked manufacturers of dermal fillers to update their labeling to reflect the possible risk of serious injuries caused by unintentional injection of the fillers into the blood vessels in the face.
A former accountant for SpineFrontier sues the orthopedic company for wrongful termination, alleging she was fired for raising concerns about regulatory issues that eventually led to an FDA warning letter.
A former accountant for SpineFrontier sued the company this month for wrongful termination, alleging that the spinal implant maker fired her for raising concerns about manufacturing processes later flagged by the FDA in a warning letter.
The China Food & Drug Administration jacks up its registration fees for medical devices and drugs to help it cope with a rising backlog of applications.
(Reuters) — The China Food & Drug Administration steeply raised the fees required to register medical devices and drugs in the world's 2nd-biggest pharmaceutical market, as a lack of resources and expertise hinders its ability to process a rising number of applications.