PubMed Literature
Medical device publications from PubMed / NCBI
Deployer-side governance of medical imaging artificial intelligence: the regulatory readiness instrument (RRI-MI) for multi-jurisdictional and post-market compliance.
Read More →Bridging Early Feasibility and Pivotal Trials: Insights From Transcatheter Tricuspid Valve Interventions.
Read More →Failure modes in soft-tissue surgical robots: an adjudicated FDA recall cohort, 2005-2026.
Read More →QAI/ML-SaMD: A Hybrid Health-Technology Quantifiable Quality Metric for Artificial Intelligence/Machine Learning-Based Software as a Medical Device.
Read More →Safety, feasibility, and outcomes of deep brain stimulation in young children excluded from the FDA Humanitarian Device Exemption: analysis of the CHILD-DBS registry.
Read More →Premarket Clinical Evidence Strength and Recalls of High-Risk Therapeutic Medical Devices.
Read More →Sleep Diagnostics and Monitoring Technology in Obstructive Sleep Apnea.
Read More →Image-based evaluation of a commercial AI synthetic CT generator for brain and prostate MR-only radiotherapy.
Read More →Review of regulatory requirements for benefit-risk assessment for medical devices: uncovering existing methodologies.
Read More →Predetermined Change Control Plan Adoption and Documentation Transparency in FDA-cleared Radiology Artificial Intelligence/Machine Learning Devices.
Read More →Risk Management of Large Language Model-Based Exercise and Health Guidance: A China-Anchored, Comparatively Informed Six-Dimensional Trigger Matrix and Lifecycle Governance Framework for the Wellness-to-SaMD Continuum.
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