PubMed Literature
Medical device publications from PubMed / NCBI
Regulatory Landscape of Regenerative Dermatology: Current Frameworks and Future.
Read More →US FDA approves home-delivered tDCS for treating depression.
Read More →Is the current regulatory framework for direct-to-consumer microbiome-based tests sufficient to protect consumers from medical, economic, and dignitary harms?
Read More →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.
Read More →Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway.
Read More →Characterization and Time-delay in Issuing High-risk Recalls of Orthopaedic Devices From 2002 to 2023.
Read More →Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting.
Read More →Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation.
Read More →Describing Inconsistencies in Pediatric Labeling of Medical Devices.
Read More →[Regulatory Practices and Implications of FDA Approving New Drug Indication under the Medical Device Pathway].
Read More →From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review".
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