FDA clears an InMed.AI 510(k) for NeuroShield, which the company describes as an automated brain geometry-based quantifying analytics tool.
FDA approves a Pacira BioSciences supplemental NDA to expand Exparels (bupivacaine liposome injectable suspension) label to include adductor canal blo...
FDA gives Brixton Biosciences a breakthrough device designation for its Coolio Therapy, which is intended to deliver long-lasting pain control in targ...
Covidien recalls its McGrath MAC Video Laryngoscope in a move to remove stolen defective models that have been offered for sale illegally.
Based on recent disappointing study data, Neurocrine Biosciences says it is stopping the development of two drugs being evaluated for treating focal o...
Federal Register notice: FDA announces an 11/29 advisory committee meeting to discuss multi-cancer detection IVDs.
The Puerto Rico federal court enters a consent decree requiring Droguera Betances, one of the territorys largest pharmaceutical distributors, to pay $...
A BMJ investigation raises concerns that the federal governments vaccine adverse event system is not operating as planned and safety signals are likel...
