PubMed 文獻
來自 PubMed / NCBI 的醫療器材文獻
Innovation trajectory of Software as a Medical Device: Evidence from the US FDA-approved products.
閱讀更多 →Pre-market clinical investigation approval pathways and the role of Early Feasibility Studies for medical devices: a scoping review to guide EU policy.
閱讀更多 →Radiation Oncology Device Recalls (2015-2025): Software and Artificial Intelligence as Emerging Drivers of Postmarket Safety.
閱讀更多 →Patient Preference Information (PPI) in Medical Device Development: A Cross-Industry Review of Use-Cases.
閱讀更多 →Regulating digital surgery to balance safety and innovation: a SAGES white paper.
閱讀更多 →Two decades of growth and trends in the FDA authorization of digital medical devices.
閱讀更多 →泌尿科的人工智能：美國食品藥品管理局批准設備的評論。
閱讀更多 →Borrowing from the cancer playbook: a master protocol basket trial for hard-to-heal wound therapeutics targeting shared pathobiology.
閱讀更多 →美國醫療設備監管的歷史和當前的監管框架。
閱讀更多 →Reliability and Consistency Analysis of Multiple Instruments for Scoliosis Screening in Adolescent Males: A Comparative Study of Instrument Accuracy.
閱讀更多 →Regulatory science for AI-based software as a medical device in computational pathology and biomarker-driven drug development.
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