IRVINE, California – August 19, 2025 – Fixstars Corporation (TSE Prime: 3687, US Headquarters: Irvine, CA),
today announced that its subsidiary, Smart Opinion Inc., has completed preparations for the implementation
of 'Smart Opinion METIS Eye' (approved as a medical device), an AI (artificial intelligence) tool to assist
doctors in diagnosing breast ultrasound (echo) examinations, have been completed and that it will begin
operation on August 19, 2025, at the the Keio University Center for Preventive Medicine in Azabudai Hills,
Minato-ku, Tokyo. Deployment to additional medical institutions is planned in sequence.
Smart Opinion is a joint venture established by Fixstars to socially implement the results of its joint
research with Keio University.
With AI, Breast Ultrasound Examinations Become More Reliable
By linking with existing examination equipment, ultrasound image AI diagnostic support software called "Smart Opinion METIS Eye" (hereinafter referred to as METIS Eye) provides diagnostic support and is capable of detecting even subtle signs of breast cancer that humans might easily miss. It was developed to support a doctor's interpretation while maintaining the conventional easy and painless ultrasound examination, supporting diagnosis with more stable accuracy than ever before, and strengthening the reliability of diagnosis by not overlooking small cancers.
A new concept for AI Breast Cancer Screening: "Smaopi"
We have named screenings utilizing the medical device program METIS Eye as "AI Breast Cancer Screening
'Smaopi'."
Medical institutions that adopt METIS Eye will not replace the physician's diagnosis, but rather use AI as
"another pair of eyes" during the physician's diagnosis. By combining "physician's diagnosis + METIS Eye,"
we will support diagnoses with even more stable accuracy than before.
By utilizing AI, we aim to enhance diagnostic reliability and provide a "more reassuring examination
experience" for individuals undergoing breast cancer screening. To achieve this recognition, we will promote
the concept of "AI Breast Cancer Screening 'Smaopi'."
Current Status of Breast Cancer Screening and the Issues Smaopi Solves
In Japan, the number of breast cancer patients has been increasing rapidly in recent years. It is currently
said that one in nine women will be diagnosed with the disease. A characteristic of breast cancer is a sharp
increase in incidence among women in their 40s. This is one of the major social issues that requires an
urgent response in a country aiming to create a society where women can play an active role.
Because breast cancer has a high probability of complete recovery and a high survival rate if detected
early, breast cancer screening is considered crucial for early detection. However, Japan's breast cancer
screening rate is 47%, which is low compared to 70-80% in Western countries, and the mortality rate from
breast cancer is increasing year by year.
Although palpation and mammography are recommended for breast cancer screening, ultrasound examination is
said to be superior to mammography for detecting invasive cancer. In particular, ultrasound can be performed
without a loss of sensitivity even in cases of dense breasts (high-density breast tissue). Dense breasts are
extremely common in younger women, and for this reason, about 40% of municipalities have voluntarily
introduced ultrasound examinations as one of their breast cancer screening options.
Unlike mammography, an ultrasound examination also has the advantage of being "painless". According to some
statistics, about 40% of women who undergo breast cancer screening opt for an echo examination, making
ultrasound a primary method of breast cancer screening. On the other hand, a challenge with ultrasound
examination has been the variability in accuracy that can arise due to the skill of the examiner.
Smaopi allows for "double reading" by both AI and a person, similar to radiation examinations, in an
ultrasound examination, which has many advantages. This leads to stable and accurate diagnoses.
References:
Ministry of Health, Labour and Welfare, "Japan's Low Screening Rate":
https://www.gankenshin50.mhlw.go.jp/campaign_2022/outline/low.html
Survey on the National Lifestyle: https://ganjoho.jp/reg_stat/statistics/stat/screening/screening.html
First Opinion on Breast Cancer "Dense Breast": https://firstopi.jp/glossary/dense_breast/
About Smart Opinion METIS Eye
- Generic Name: Program for ultrasound workstation
- Trade Name: Breast Cancer Ultrasound Image AI Diagnosis Support Software Smart Opinion METIS Eye
- Approval Number: 30600BZX00086000
- Classification: Controlled Medical Device (Class II)
METIS Eye was developed based on technology resulting from joint research between Keio University and
Fixstars Corporation, with the aim of assisting physicians in image interpretation and preventing oversight.
It obtained pharmaceutical approval as a medical device program in May 2024. As breast cancer screening is a
place to determine whether or not a case requires a detailed examination, it detects candidate lesion sites
suspected of requiring a detailed examination and determines the necessity of a detailed examination based
on the international standard BI-RADS category classification for those candidate lesion sites.
The detection sensitivity for findings suspected of requiring a detailed examination is 94.4%, and a
statistically significant difference was observed between a doctor's diagnosis with and without the
AI.[1] When used in conjunction with a Picture Archiving and Communication System (PACS), METIS
Eye seamlessly analyzes captured images and saves the results in the PACS. Doctors can review the analysis
results from METIS Eye on the PACS viewer without changing their existing screening workflow, creating a
so-called double-reading format.
Reference: BI-RADS Category Classification https://firstopi.jp/screening/risky_result/risky_result_drhayashida/
[1] Average value of evaluation test results for image interpretation of 50 breast ultrasound images targeting 24 physicians.
"Smart Opinion METIS Eye" Detection Result Image
Comment from Dr. Satoru Hayashida, Professor, Department of Surgery (Breast Surgery), Keio University School of Medicine, and a joint developer
Breast ultrasound examination can be performed painlessly and is considered highly likely to be a particularly useful examination method for Japanese women, who often have dense breasts. However, there are disparities in diagnostic technology between regions and facilities, which can lead to disadvantages such as oversights and unnecessary detailed examinations. With AI providing diagnostic accuracy at the highest level, I hope this technology will eliminate such disparities and allow women to undergo breast cancer screening with greater confidence.
About Smart Opinion
Smart Opinion Inc., established in October 2019 as a joint venture between Fixstars Corporation (Tokyo
Stock Exchange Prime: 3687) and Prodigy Medical Inc., contributes to improving early detection of breast
cancer and promoting women's health by developing and disseminating "AI Breast Cancer Screening 'Smaopi'",
an ultrasound examination that can image-diagnose suspected breast cancer using AI technology. It also
provides patient support services and women's health management support services that realize
"patient-centered" healthcare utilizing digital and IT.
https://www.smaopi.com/
About Fixstars Corporation
Fixstars is a technology company dedicated to accelerating AI inference and training through advanced software optimization solutions. It supports innovation in healthcare, manufacturing, finance, mobility, and other industries. For more information, visit: https://www.fixstars.com/
