Three stakeholders recommend improvements to an FDA draft guidance on testing and labeling medical devices for safety in the magnetic resonance enviro...
FDA says a Medtronic recall of its MiniMed insulin pumps due to potential cybersecurity risks is Class 1.
Sens. Warren and Murray raises objections to and questions about an FDA proposal for a progressive approval pathway for medical devices.
FDA releases its latest batch of Warning Letters that includes one medical product company Bingbing Pharmaceutical.
Abbott recalls its CentriMag Acute Circulatory Support System due to a calibration system error.
FDA says a requested clinical trial did not alleviate an overall survival trend that it was concerned with in an earlier Aveo Oncology study of tivoza...
Aquestive Therapeutics asks FDA not to approve Neurelis Valtoco until the company performs additional studies like those Aquestive performed for its L...
Tonix Pharmaceuticals says that after receiving input from FDA, it is changing elements of its Phase 3 study of its Tonmya PTSD treatment.