FDA clears a de novo marketing request from Vela Diagnostics USA for its Sentosa SQ HIV Genotyping Assay for detecting human immunodeficiency virus Ty...
Three stakeholders recommend improvements to an FDA draft guidance on testing and labeling medical devices for safety in the magnetic resonance enviro...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.
CDER researchers look at why oncology INDs are placed on clinical hold.
Fagron recalls its Lets Gel Kit Convenience Packs due to potential microbial contamination of non-sterile products.
Philips Medical Systems recalls (Class 1) the Forte Gamma Camera System due to a nonconforming material/component.