Resources

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  Medical Metrics

  • Others
  • Imaging
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  Introduction to FDA Guidance on the Development of SaMD (Chinese version)

  • White Paper
  • SaMD
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  Micron’s ViewPoint　第20号（医疗器械软件(SaMD)的开发- FDA指南简介-）中文版

  • White Paper
  • SaMD
  • AI
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  FDA Guidance Clinical Trial Imaging Endpoint Process Standards 1 -Background for planning an imaging study-

  • Video
  • Imaging
  • Guidance
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  FDA Guidance Clinical Trial Imaging Endpoint Process Standards 2 -Micron’s experience-

  • Video
  • Imaging
  • Guidance
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  Imaging Biomarkers for the efficacy evaluation of regenerative medicine

  • Video
  • Imaging
  • Regenerative
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  Standardization of clinical trials imaging endpoints

  • Video
  • Imaging
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  Solution for De-Identification Failure of DICOM Images

  • Video
  • Imaging
  • Products
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  Image Uploading and Reporting System：IRUMneo＆i-Boarding

  • Video
  • Imaging
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  Comparison of the CDE Guidance and the FDA Guidance for Antitumor Clinical Trials using Imaging Endpoints

  • Video
  • Imaging
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  ATRaS Demonstration

  • Video
  • Imaging
  • Products
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  Computer-Aided Detection/Diagnosis (CAD) Using AI

  • Others
  • SaMD
  • AI
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  Regulatory Process for Medical Device Software in Japan

  • Others
  • SaMD
  • Guidance
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  Satety Evaluation of Anti-Amyloid-β Antibodies in Alzheimer’s Disease – ARIA (Chinese version)

  • White Paper
  • Imaging
  • CNS
  • MRI
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  Satety Evaluation of Anti-Amyloid-β Antibodies in Alzheimer’s Disease – ARIA

  • White Paper
  • Imaging
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  Micron’s ViewPoint　第19号（阿尔茨海默病中抗β淀粉样蛋白抗体的安全性评价​～ARIA～）中文版

  • White Paper
  • Imaging
  • CNS
  • MRI
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  The Utilization Situation of Imaging Endpoints – An Imaging Endpoint List –

  • White Paper
  • Imaging
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  The Methodology of Centralized Image Interpretation and Roles of an Imaging CRO: Centralized Image Interpretation Variations​

  • White Paper
  • Imaging
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  The Methodology of Centralized Image Interpretation and Roles of an Imaging CRO: An Overview

  • White Paper
  • Imaging
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  Chinese Materials

  • White Paper
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  The Development of Software as a Medical Device (SaMD) -Clarification of Clinical Significance-

  • White Paper
  • SaMD
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  Publication Notice Clinical Trials for ​Medical Imaging Diagnostic Decision Support Systems​ – The Social Implementation of Medical Artificial Intelligence -​

  • White Paper
  • SaMD
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  Publication Notice Clinical Application of a Brain Image Analysis Program for Multiple Sclerosis Part 3: Clinical Significance of “Brain Volume Visualization” A Treatment Strategy for Long-Term Prognosis

  • White Paper
  • Imaging
  • CNS
  • MRI
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  Publication Notice Clinical Application of a Brain Image Analysis Program for Multiple Sclerosis Part 2: The Usefulness in Multiple Sclerosis Treatment: Potential of Being a Part of a New Evaluation Scale

  • White Paper
  • Imaging
  • CNS
  • MRI
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  Publication Notice Clinical Application of a Brain Image Analysis Program for Multiple Sclerosis Part 1: Multiple Sclerosis and Diagnostic Imaging

  • White Paper
  • Imaging
  • CNS
  • MRI
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  Kobe Cardiovascular Core Laboratory – Introduction on the Service for Clinical Trials Using Intravascular Imaging Endpoints

  • White Paper
  • Imaging
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  iRECIST Overview

  • White Paper
  • Imaging
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  Clinical Evaluation of AI medical image diagnostic software: The Importance of the Reference Standards

  • White Paper
  • SaMD