https://microncro.com/information_en/mvp20-2/

The U.S. Food and Drug Administration (FDA) announced the final revised guidance titled “Clinical Performance Assessment: Considerations for Computer Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k))”(referred to as the “FDA Guidance” below) in September 2022. This issue offers insights in Chinese on key aspects of the FDA Guidance that are particularly important for formulating the clinical trial design of Computer Assisted Detection (CADe) systems.

 

Micron’s ViewPoint Introduction to FDA Guidance on the Development of SaMD(Chinese version)

https://microncro.com/information_en/mvp19-2/

Micron’s ViewPoint Satety Evaluation of Anti-Amyloid-β Antibodies in Alzheimer’s Disease – ARIA (Chinese version)

This paper provides an Chinese overview of ARIA, including a summary of ARIA imaging evaluation in clinical trials related to anti-Aβ antibodies.
Please click this link to see the white paper.

 

【Micron’s ViewPoint】阿尔茨海默病中抗β淀粉样蛋白抗体的安全性评价~ARIA~

https://microncro.com/information_en/mvp22/

This paper provides an overview of ARIA, including a summary of ARIA imaging evaluation in clinical trials related to anti-Aβ antibodies.

Please click this link to see the white paper.

https://microncro.com/information_en/mvp18/

Over the past quarter-century, imaging endpoints have been used in many clinical trials for drug and medical device development. In this article, we analyze the use of imaging endpoints in each disease based on information from ClinicalTrials.gov, and summarize the imaging endpoints that are frequently used in each disease category.

Please click this link to see the white paper.

https://microncro.com/information_en/mvp16/

We would like to introduce the types of central review according to their roles and characteristics when designing central review.
By defining the roles and objectives of central review in each clinical trial, the central review would be performed more efficiently and effectively. When objectives and roles are well defined, each step of the central review can be designed in detail.

Please click this link to see the white paper.

https://microncro.com/information_en/mvp12/

In this article, we would like to provide an overview of central review.
Imaging central review should be properly designed to minimize bias and maximize the accuracy of clinical trial results, working with Imaging CROs as needed.

Please click this link to see the white paper.

https://microncro.com/information_en/mvp17/

Clarification of clinical significance is very important in the development of SaMDs (Software as a Medical Device) that have become active in recent years.
This whitepaper summarizes the items that should be considered when clarifying the clinical significance based on the “Guidelines of Determining Whether Software is Classified as a Medical Device” issued by the Ministry of Health, Labour and Welfare (MHLW) of Japan in 2021.

 

The Development of Software as a Medical Device (SaMD) – Clarification of Clinical Significance –

https://microncro.com/information_en/mvp11/

With the recent development of AI technology, the development of AI-equipped computer-aided detection/diagnosis (CAD : Computer-Aided Detection/Diagnosis) has been actively promoted in the field of diagnostic imaging. However, there are many barriers to the social implementation of AI-CAD, such as image data collection, clinical trials, and regulatory approval.

In this article, we will introduce the overall picture of clinical trials of medical imaging support systems including AI-CAD.
We hope that you will enjoy it.

Micron’s ViewPoint has been published.
Micron’s ViewPoint Publication Notice
Clinical Trials for ​Medical Imaging Diagnostic Decision Support Systems
– The Social Implementation of Medical Artificial Intelligence -​

https://microncro.com/information_en/mvp15/

We would like to share the third article, the final article in the series by Dr. Kenzo Sakurai of St. Marianna University School of Medicine titled: “Clinical Significance of ‘Brain Volume Visualization’: A Treatment Strategy for Long-Term Prognosis” from the series “Clinical Application of a Brain Image Analysis Program for Multiple Sclerosis.”

In this article, there is a discussion how to apply a brain imaging analysis program to actual clinical practice. We hope that you will enjoy it.

Micron’s ViewPoint has been published.
Micron’s ViewPoint 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

https://microncro.com/information_en/multiple_sclerosis_2/

We would like to share the second article written by Dr. Kenzo Sakurai of St. Marianna University School of Medicine titled: “The Usefulness in Multiple Sclerosis Treatment: Potential of Being a Part of a New Evaluation Scale” from the series “Clinical Application of a Brain Image Analysis Programfor Multiple Sclerosis.”

In this second article, there is a discussion of the possibility of a new evaluation method based on an actual case in which brain volume was measured by a brain image analysis program. We hope that you will enjoy it.

Micron’s ViewPoint has been published.
Micron’s ViewPoint 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