PubMed Literature
Medical device publications from PubMed / NCBI
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".
Read More →Development trend of Artificial Intelligence (AI) in dentistry: exploring FDA-cleared dental devices.
Read More →Translational Evaluation of a Machine Learning-Based Interactive Lab for Aphasia Rehabilitation in Post Stroke Patients.
Read More →FDA-authorized software as a medical device in mental health: a perspective on evidence, device lineage, and regulatory challenges.
Read More →Regulatory Challenges and Opportunities: A Review of U.S. Food and Drug Administration-Approved Artificial Intelligence and Machine Learning-Enabled Cardiovascular Devices.
Read More →Comparison of two models of biofilm formation on reusable stainless steel medical device material.
Read More →No matching articles.
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