https://microncro.com/information_en/medica2022/

We are going to participate in MEDICA 2022 in Düsseldorf, Germany.
Micron has been selected by JETRO (Japan External Trade Organization) and Osaka Prefecture as a supported company and will exhibit at the Osaka booth in the Japan Pavilion at MEDICA 2022.

We are going to introduce our experience in regulatory affairs and sales of SaMD (Software as a Medical Device).
Please feel free to come and visit our booth.

Date    : November 14, 2022 – November 17, 2022
Location: Düsseldorf Trade Fair Center
Booth number:H02 / Hall 15
Web site:https://www.medica-tradefair.com/vis/v1/en/exhibitors/medcom2022.2723738?oid=80396&lang=2&ticket=27406827647851&_query=micron

Please contact :
Micron, Inc. Sales and Marketing Department
E-mail:info@micron20231006.local

 

Go to JETRO’s article : 世界最大の医療機器展「MEDICA 2022」 ジャパン・パビリオン出展企業22社を採択 ―注目スタートアップ等、日本企業の海外市場への挑戦を後押し、輸出拡大を目指す―

https://microncro.com/information_en/dia-japan2021/

We exhibit at the 18th DIA Japan Annual Meeting 2021. This year’s event will be held on the web as last year.

Under the theme of “A company that comprehensively researches and evolves imaging”, Micron, Inc. has been working to efficiently support clinical trials by utilizing imaging technology. We will be exhibiting the following services. Please come and visit our virtual booth.
 
Web exhibition: October 17, 2021 – November 30, 2021
 
The 18th DIA Japan Annual Meeting 2021 https://diajam2021.ap1.pathable.com/
Micron’s booth https://diajam2021.ap1.pathable.com/organizations/QJSnTtRnikageA7Wh
Only attendees of the DIA Japan Annual Meeting can visit. (Please feel free to contact us in case you’re not an attendee.)
 
[INDICATE Building Bridges with the Medical Device Industry]
We adopt, introduce, and propose image analysis technologies with advanced technology, such as those equipped with artificial intelligence (AI). We act as a bridge between companies that want to introduce innovative software as medical device (SaMD) and companies which are interested in them.
 
[Support for obtaining approval for diagnostic imaging programs (SaMD)
What should be prepared to launch a programmed medical device (AI medical diagnostic aid software) in Japan? We will introduce you Micron’s solutions. We propose solutions from imaging study design and operation to PMDA consultation and application.
 
[Solution for de-identification failure solution during DICOM image retrieval in clinical trials]
Solution for one of the most common queries in clinical trials using images, the omission of subject information deletion.
 
[Micron Service General Information]
Micron’s services introductions.
 
Please feel free to contact us regrading this article.
Micron, Inc.
E-mail: info@micron20230721.local
https://microncro.com/information_en/proswell_webinar2021_0413/

Following our successful webinar in March, we are pleased to announce the second in a series of seminars on China’s Center for Drug Evaluation (CDE) guidance at Proswell University, hosted by our Chinese partner Proswell Medical Company.

 

On January 15th, 2021, China’s CDE published guidelines on imaging criteria for anti-tumor drug clinical trials. In recent years, there have been a large number of clinical trials related to anti-cancer drugs in China, and more and more clinical trials are using medical imaging evaluation from the early stage of development.

 

In this presentation, we will compare the CDE guidance with the Clinical Trial Imaging Endpoint Process Standards Guidance for Industry published by the US FDA and provide examples based on our own experience.

 

Date and time:.

Tuesday, April 13th, 2021, 16:00-17:00 Japan time (15:00-16:00 Beijing time)

 

Speaker: Zheng Tong, Department of Image Analysis Micron, Inc.

 

 

Title (all in Chinese):

  1. Understanding the differences in evaluation results

– Common misunderstandings

– Differences between institutional evaluations and independent evaluation committee evaluations

– Differences between Independent Review Committee Evaluators

  1. Quality control of medical images

– Explanation of guidance content

  1. Quality control for independent assessment

– Explanation of guidance content

  1. Reference points for the quality of independent image assessment services

– Explanation of guidance related content

– Requirements

 

Registration Fee: Free of charge.

Advance registration via Proswell Medical Company’s WeChat site is required.

https://mp.weixin.qq.com/s/KGQIp9UCSi0UUIxKS-4XJA

https://microncro.com/information_en/proswell_webinar2021/

On January 15, 2021, China CDE (Center for Drug Evaluation) published guidelines on image evaluation criteria for anti-tumor drug clinical trials. In recent years, a large number of clinical trials related to anti-cancer drugs have been conducted in China, and the number of clinical trials that use medical imaging evaluation from the early development stage is on the rise.

We are pleased to announce that our partner CRO in China, Proswell Medical Company, has invited Professor Ukihide Tateishi of Tokyo Medical and Dental University to present a web seminar at Proswell University. In this seminar, we will compare the CDE guidance and  the Clinical Trial Imaging Endpoint Process Standards Guidance for Industry released by the US FDA in 2018, and explain the importance of standardization in imaging trials with our experience.

 

Date:

March 16, 2021 (Tue) 16:00-17:00 JST (15:00-16:00 BST)

 

Speakers:

Ukihide Tateishi, MD, PhD, Professor at Department of Diagnostic Radiology, Tokyo Medical and Dental University

Zheng Tong, Department of Image Analysis Micron, Inc.

 

Agenda:

Part 1. Interpretation of the CDE guidelines – with reference to Micron’s efforts in Japan 

  1. Use of Independent Review Committees
    • Comparison between FDA guidance and CDE guideline
    • What are the benefits of using independent central review?
    • IRC case example
  2. Design of Independent Review Process and Timing of Evaluation
    • Study design
    • Image data review method
    • Evaluation timing
  3. Criteria for imaging endpoints
    • Comparison of public comments version and official version
    • Determination of evaluation criteria
  4. Use of FDG-PET
    • Comparison of public comments version and official version
    • Standardization of qualitative and quantitative evaluations

 

Part 2: Standardization of PDG-PET / CT

  1. Procedures and Criteria for Standard FDG-PET/CT: Recent Progress

  RSNA-QIBA (RSNA-Quantitative Imaging Biomarler Allegiance)

  JRS-QIBA (Japan Radiologic Society-QIBA)

  JSNM WG (Japanese Society of Nuclear Medicine-Tateishi Working Group)

  1. Approved Clinical Trial of Asian Multicenter Phase-II in Cooperation with MICRON Inc.

 

Fee:

Free of charge. Advance registration through Proswell Medical Company’s WeChat site is required.

 

Part 1 will be conducted in Chinese and Part 2 in English. No Japanese interpretation will be provided.

 

How to register and other details

Please refer to the following Proswell Medical Company website.

https://www.proswell.com.cn/post.html?id=604048d21cca8a09123c67f7

 

 

Micron, Inc. has entered into a business alliance agreement with Proswell Medical Company. To mark this alliance, one of our employees will be speaking at their web seminar called “Proswell University. (Note: This seminar will be in Chinese.)

https://microncro.com/information_en/medical-fair-asia-2020-digital-edition/

Micron joins this Asian biggest medical device exhibition which is usually held in Singapore. Please feel free to visit our virtual showcase. (Free registration)

 

December 9 – 18, 2020

To visit our virtual booth (free registration required)

https://www.medicalfair-asia.com/registration.html

 

Micron’s showcase information

https://www.medicalfair-asia.com/product-highlights.html?eid=502

 

Perfusion Image Analysis Software

A medical image analysis program automatically analyzes cerebral blood flow information, which is connectable to PACS. An application which provides information for making decisions, and diagnosis related to pathological conditions using CT perfusion images (CTP) and MR Diffusion-weighted images (DWI)/Perfusion weighted images (PWI).

 

This software was marketed in Japan on April 13, 2020, and is used to support physicians to select patients with acute stroke for thrombectomy and improving the workflow. In order to deliver this software outside of Japan, we’re take this opportunity to introduce its       functions and features with videos.

 

ATRaS, DICOM Viewer and De-Identification Software

ATRaS has a DICOM image anonymization function, DICOM tag editing/comparison function, image viewer function, etc. Based on the  know-how accumulated as an imaging CRO, this software has been developed to prevent the leakage of personal information in clinical trials and clinical research at a reasonable price.

 

We are waiting for your visit with further products/services. See you soon at MEDICAL FAIR ASIA 2020!

 

Please feel free to contact us regrading this article.

Micron, Inc.

E-mail:image_sales@micron20230721.local

https://microncro.com/information_en/virtual-medica-2020/

Micron, Inc. will exhibit software at MEDICA 2020. This year, MEDICA will be held online.

 

November 16 – 19, 2020

Micron’s virtual booth (URL accessible to everyone)

https://www.medica-tradefair.com/vis/v1/en/exhibitors/medcom2020.2677024?oid=80396&lang=2

 

 

Perfusion Image Analysis Software

A medical image analysis program automatically analyzes cerebral blood flow information, which is connectable to PACS. An application which provides information for making decisions, and diagnosis related to pathological conditions using CT perfusion images (CTP) and MR Diffusion-weighted images (DWI)/Perfusion weighted images (PWI).

 

This software was marketed in Japan on April 13, 2020, and is used to support physicians to select patients with acute stroke for thrombectomy and improving the workflow. In order to deliver this software to many users, we would like to take this opportunity to introduce its functions and features.

 

ATRaS, DICOM Viewer and De-Identification Software

ATRaS has a DICOM image anonymization function, DICOM tag editing/comparison function, image viewer function, etc. Based on the  know-how accumulated as an imaging CRO, this software has been developed to prevent the leakage of personal information in clinical trials and clinical research at a reasonable price.

 

We are looking forward to getting in touch with many companies at virtual.MEDICA 2020. Please visit our virtual booth.

 

Please feel free to contact us regrading this article.

Micron, Inc.

E-mail:image_sales@micron20230721.local

https://microncro.com/information_en/dia-japan2020/

We’re going to showcase our services at the 17the DIA Japan Annual Meeting 2020. This year’s exhibition will be held entirely online.

Under the theme of “A company that comprehensively studies and evolves imaging” Micron has been working to efficiently support clinical trials by utilizing imaging technologies. This time, we are exhibiting the following services. Please visit our virtual booth.

 

November 8 – 10, 2020

https://www.diaglobal.org/en/conference-listing/meetings/2020/11/17th-dia-japan-annual-meeting-2020/exhibits#showcontent

 

[Support for clinical trials of cerebral infarction]

Propose efficient subject evaluation using brain perfusion image analysis data.

[Masking failure solution during DICOM image retrieval in clinical trials]

Propose a solution for one of the most common queries in clinical trials using images, failure to delete subject information.

[Support for obtaining approval for diagnostic imaging drugs and programs]

Propose solutions from imaging study design and operation through PMDA consultation and application supports in clinical trials of   diagnostic imaging agents.

What does a AI manufacturer need to do to market a programmed medical device (AI Medical Imaging Support Software) in Japan?  Introduce Micron’s experiences.

 

Please feel free to contact us regrading this article.

Micron, Inc.

E-mailimagingbiomarker@micron20230721.local

 

https://microncro.com/information_en/proswell_webinar2020_oct13/

Topic: Imaging Assessments and Recent Trends in Clinical Trials in the Central Nervous System – Focusing on MRI –《中枢神经系统的临床试验中影像学检查(MRI)的最新趋势》

Speaker: Dr. Mari Anzai Micron, Inc. Imaging Service Department

Time: Oct 13, 2020 16:00 Japan time (15:00 in Beijing time

 

Description:

In the field of Central Nervous System, image assessments using MRI is considered important. In particular, in clinical trials using imaging as an assessment item, qualitative and quantitative evaluations are performed in many cases, unlike imaging conditions used in daily medical practice. Standardization of MRI imaging conditions in multi-center clinical trials is an important point. This lecture will focus on the standardization of MRI imaging conditions for Central Nervous System diseases.

 

How to register:

Please refer to Proswell Medical Company’s website

https://mp.weixin.qq.com/s/hzX25Nql1NUo06V4qSkxrg

https://microncro.com/information_en/proswell_webinar2020/

Micron, Inc. has entered into a business alliance agreement with Proswell Medical Company. To mark this alliance, one of our employees will be speaking at their web seminar called “Proswell University.” (Note: This seminar will be in Chinese.)

 

Topic: Anti-Tumor Clinical Trial Design: Error Sources and Countermeasures for the Imaging Endpoint Process

         (中国語題:抗肿瘤药的临床试验设计:影像终点程序中的误差因素和对应方法)

 Speaker: Dr. Mari Anzai Micron, Inc. Imaging Service Department

 Time: Aug 24, 2020 16:00 Japan time (15:00 in Beijing time

 

Description:

In the field of developing anti-tumor drugs, imaging endpoints, such as the objective response rate (ORR), progression-free survival     (PFS), etc., are assessed using medical images, namely CT, MRI, and PET, have become widely used in clinical trials. Acquiring the        imaging endpoints includes scanning to obtain images, assessing the image data, and so on. During scanning, imaging manufacturer     discrepancies, scanning parameter settings, and other factors may result in imaging endpoint errors. On the other hand, during the       assessment, the reader’s subjective judgment or assessment bias may also result in endpoint errors. The standardization of scanning    and assessment is necessary to avoid errors and acquire accurate study     results. This lecture will focus on the source of errors in the results and the corresponding resolutions.

 

How to register:

Please refer to Proswell Medical Company’s website

https://www.proswell.com.cn/post.html?id=5f1242271cca8a46d26e2480