How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals
Eric Q. Wu, Kevin Wu, Roxana Daneshjou, David Ouyang, Daniel E. Ho, James Zou
Topics & Concepts
Food and drug administrationDrug approvalMedical deviceMedicineRisk analysis (engineering)DrugPharmacologyBiomedical engineeringArtificial Intelligence in Healthcare and EducationEthics in Clinical ResearchMachine Learning in Healthcare