What is required to market the SaMD* (AI based medical image diagnostic assistance software) in Japan??

Advances in AI technology have increased the performance of CAD ( Computer-Aided Diagnosis / Detection ), a medical imaging support system that uses AI, to a level that meets the expectations of clinical practice. As an imaging CRO, Micron  has the know-how to conduct surveys similar to CAD products, create reference standards for medical images, assist in the design and implementation of performance verification tests, and analyze ROC. As a result, Micron is able to respond to a variety of requests.

 

 

 

Micron offers a comprehensive range of services for medical image diagnosis support system certification and approval, including consultation, test planning and operation, and response upon approval application by PMDA. We also provide training services for medical image diagnosis support systems that require certification and approval. 

 

PMDA Application Support Professional for Imaging diagnosis/ diagnosis assistance AI based SaMD

 

 

 

Related:


Computer-Aided Detection/Diagnosis (CAD) Using AI

Micron’s ViewPoint / Clinical Evaluation of AI medical image diagnostic software: The Importance of the Reference Standards