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Face-to-face advice preparation interview by Pharmaceuticals and Medical Devices Agency for dementia diagnosis support AI system has been completed
FRONTEO is pleased to announce that the Pharmaceuticals and Medical Devices Agency (PMDA) has completed a face-to-face advice preparation interview regarding the dementia diagnosis support AI system (medical device).
The interview is one of the necessary processes for developing pharmaceuticals and medical devices.With the completion of this interview, PMDA will be able to provide specific consultation regarding clinical trials.When conducting a clinical trial for regulatory approval, PMDA will provide guidance and advice for conducting the clinical trial properly, such as confirming whether the study design is based on scientific evidence, giving maximum consideration to the safety of the subject. After receiving this, we will proceed with preparations for the start of the clinical trial, such as formulating a clinical trial plan.
This system is the world's first system that can support the diagnosis of dementia through natural conversations rather than specialized conversations and interviews, and is the first medical device in the world to utilize linguistic artificial intelligence (AI) in Japan. We are aiming for early approval in Japan.
Please see here for the dementia diagnosis support AI system.