Systematic analysis of the test design and performance of ai/ml-based medical devices approved for triage/detection/diagnosis in the usa and japan

HIGHLIGHTS

• who: Mitsuru Yuba from the diagnosis in the USAMedical University have published the research work: Systematic analysis of the test design and performance of AI/ML-based medical devices approved for triage/detection/diagnosis in the USA and Japan, in the Journal: Scientific Reports Scientific Reports of June/22,/2021
• what: The authors investigate the AI/ML-based CAD devices approved by the FDA and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and analyzed their requirements in terms of target and study design to provide insights into the global development of AI/ML . . .
  

   

  

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