PubMed文献
PubMed / NCBIの医療機器関連文献
Systematic review of usability evaluations in medical devices: Methodological choices, heuristic application, and confounding factors.
続きを読む →Regulatory Landscape of Regenerative Dermatology: Current Frameworks and Future.
続きを読む →US FDAは自宅配達のtDCSをうつ病治療用として承認
続きを読む →Is the current regulatory framework for direct-to-consumer microbiome-based tests sufficient to protect consumers from medical, economic, and dignitary harms?
続きを読む →Clinical Evidence to Support US Food and Drug Administration Review of New Medical Technology in Pulmonary, Sleep, and Critical Care Medicine Between 2014 and 2024: A Scoping Review to Support Adoption in Practice.
続きを読む →Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway.
続きを読む →Characterization and Time-delay in Issuing High-risk Recalls of Orthopaedic Devices From 2002 to 2023.
続きを読む →Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting.
続きを読む →Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation.
続きを読む →Describing Inconsistencies in Pediatric Labeling of Medical Devices.
続きを読む →[Regulatory Practices and Implications of FDA Approving New Drug Indication under the Medical Device Pathway].
続きを読む →一致する論文はありません。
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