FRONTEO obtains first-class medical device manufacturing and sales license

2021.01.18 Press release

--To the press -

FRONTEO obtains first-class medical device manufacturing and sales license

Full-scale start for manufacturing and sales of conversational dementia diagnosis support AI system as a medical device

Masahiro Morimoto, President and CEO
2-12-23 Konan, Minato-ku, Tokyo
(Code number: 2158 TSE Mothers)

 FRONTEO Inc. (Headquarters: Minato-ku, Tokyo, President: Masahiro Morimoto, hereinafter FRONTEO) licensed the first-class medical device manufacturing and sales business from Tokyo on January 1.(Permission number: 13B1X10350) has been acquired.


 FRONTEO submitted a medical device manufacturing and sales license application to the Tokyo Metropolitan Government on November 2020, 11, and the Governor of Tokyo has approved the first-class medical device manufacturing and sales business.As a result, FRONTEO will be able to carry out everything from technological development of AI medical devices to product development, clinical development, manufacturing and sales in-house, and will be able to build the first one-stop model of language-based AI medical devices in Japan.This system construction is one of the important elements in FRONTEO's future life science business strategy.

 FRONTEO is currently preparing to start clinical trials of the world's first conversational dementia diagnosis support AI system.Starting with the development of this system, we are developing AI medical devices that utilize the latest technology, and are working to contribute to improving the efficiency and quality of medical care, reducing the burden on patients, families, and medical staff, and improving QoL. I will come.


* What is a first-class medical device manufacturing and sales license?

In Japan, the manufacture and sale of pharmaceuticals and medical devices is regulated by the "Act on Securing Quality, Effectiveness and Safety of Pharmaceuticals and Medical Devices" (commonly known as the Pharmaceutical Machinery Law), and the Ministry of Health, Labor and Welfare and prefectures It is necessary to obtain the permission and approval of.The medical device manufacturing and sales business is a business format that ships and markets medical devices and is responsible for the effectiveness, safety, and quality of the products.We carry out safety and quality control when actually using medical devices, as well as collecting, analyzing, and responding to the necessary information, including applications and notifications for approval of medical devices.Medical devices are classified into classes I to IV according to the degree of risk given to users, and the types of business licenses required differ depending on this class.The first-class medical device manufacturing and sales business is a qualification that enables the handling of all classes of medical devices.




FRONTEO supports corporate business by extracting meaningful and important information from a huge amount of text data using the in-house developed AI engine "KIBIT®" and "concept encoder®" that specialize in natural language processing. It is a data analysis company. Since its establishment in August 2003, it has been expanding globally to Japan, the United States, South Korea, and Taiwan, with a focus on legal tech businesses such as "e-discovery (electronic discovery)" and "digital forensic investigation" that support international litigation of companies. Has been deployed.Based on the AI ​​technology cultivated in the legal tech business, we will expand the business field to the life science field and business intelligence field from 8, and use AI to "turn text data into knowledge" to support drug discovery. , Dementia diagnosis support, financial, personnel, sales support, etc., contributing to solving various corporate issues. Listed on TSE Mothers on June 2014, 2007.The capital is 6 thousand yen (as of March 26, 2,568,651).


<Contact information for the press>
Public Relations Officer, FRONTEO Inc. Segawa


<Inquiries about Life Science AI Business>
FRONTEO Inc. Life Science AI Business Headquarters


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