Computer-aided detection/diagnosis (CAD) are generally defined as systems that assist doctors to interpret medical images and make diagnostic decisions. Advancing along with generation by generation, CAD products have been improving their performance to meet the clinical needs. Notably, the accomplishments of CAD are highly expected since artificial intelligence (AI) technology with high image processing ability has been used in system development.
It is necessary to prove efficacy before a new CAD product can be applied to clinical sites. A good result of the CAD product only by itself may not be enough. (For example, good accuracy in detecting lesions by using the image data is also used in the development.) It may be necessary to demonstrate specifically to acquire the authorities’ approval. The essential question in approval qualifications is:
What kind of benefit can the new CAD system bring to the real clinical world?
If you are considering entering the Japanese market, Micron may be your best choice for a partner to acquire approval. We provide extensive services from the beginning of market positioning and clinical trial design based on the consultation with PMDA, the conduction of clinical performance study (reader study), and to the submission of the final documents for approval.
An Example of Micron’s Workflow: Assisting CAD Approval
Micron’s Work Experience of Assisting CAD Approval