FDA issues safety alert on a higher-than-expected risk of device failure with DT MedTechs Hintermann Series H3 Total Ankle Replacement system.
CBER director Peter Marks says he expects 2024 to be a big year for gene therapy approvals as several Center initiatives take hold to advance product ...
Four stakeholders update comments on the latest version of an FDA draft guidance on topical ophthalmic products.
Three stakeholder organizations raise many questions about and objections to an FDA proposed rule on wound products.
FDA commissioner Robert Califf expresses concern about fake and compounded weight-loss drugs and the disparity in the availability of branded weight-l...
FDA clears a Nevro 510(k) for its Nevro1 sacroiliac joint fusion device for treating chronic SI joint pain.
Medtronic Neurology recalls its Duet External Drainage and Monitoring System, which is used to drain cerebrospinal fluid (CSF) to reduce intracranial ...
An HHS-funded RAND study finds that many new drugs are available in the U.S. before launching in other countries.
