PubMed文献
PubMed / NCBIの医療機器関連文献
Failure modes in soft-tissue surgical robots: an adjudicated FDA recall cohort, 2005-2026.
続きを読む →Privacy policies for FDA-authorized or FDA-recognized digital therapeutics impose high digital health literacy demands: a cross-sectional analysis.
続きを読む →QAI/ML-SaMD: A Hybrid Health-Technology Quantifiable Quality Metric for Artificial Intelligence/Machine Learning-Based Software as a Medical Device.
続きを読む →Safety, feasibility, and outcomes of deep brain stimulation in young children excluded from the FDA Humanitarian Device Exemption: analysis of the CHILD-DBS registry.
続きを読む →Premarket Clinical Evidence Strength and Recalls of High-Risk Therapeutic Medical Devices.
続きを読む →Sleep Diagnostics and Monitoring Technology in Obstructive Sleep Apnea.
続きを読む →Review of regulatory requirements for benefit-risk assessment for medical devices: uncovering existing methodologies.
続きを読む →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.
続きを読む →Interventional, multicentre investigation of a novel lumbar total joint replacement: propensity matched study design and protocol.
続きを読む →R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 27.
続きを読む →Three Decades of Food and Drug Administration Authorizations of Artificial Intelligence/Machine Learning-Enabled Medical Devices: Persistent Specialty Concentration and the Care-Delivery Gap (1995-2025).
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