FDA clears a Lunit 510(k) for its Insight MMG, an artificial intelligence application for breast cancer detection.
FDA says it is working with Medtronic to evaluate outcomes after cardiac perforation following implantation of leadless pacemaker systems.
FDA approves a new renal cell carcinoma indication for Mercks Keytruda.
FDA says its Division of Drug Information pharmacists are available to answer consumer questions about taking drugs.
FDA updates possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products.
FDA tells a Texas federal court it needs until 2076 to respond to a Public Health and Medical Professionals for Transparency request for information o...
FDA says AB Science can resume enrollment of ALS patients in a Phase 3 study of masitinib.
FDA qualifies the MED Institutes medical device development tool for virtual MRI safety evaluations of patients with implanted medical devices.