FRONTEO Inc. (Headquarters: Minato-ku, Tokyo, Representative Director: Masahiro Morimoto, hereinafter FRONTEO) submitted a first-class medical device manufacturing and sales license application to Tokyo on November 11.

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 they pose to users, and the requirements for business licenses differ depending on this class.The first-class medical device manufacturing and sales business that FRONTEO has applied for is a qualification that enables the handling of all classes of medical devices.

FRONTEO will be able to develop and sell AI medical devices in-house by obtaining a medical device manufacturing and sales license.This is a very important process for us to start full-scale business in the life science AI field and become a “globally accepted AI medical device company”. FRONTEO is currently jointly developing the world's first conversational dementia diagnosis support AI * with Kyowa Pharmaceutical Industry Co., Ltd. (Headquarters: Osaka City, Osaka Prefecture, President: Noriaki Tsunoda), and is conducting clinical trials from 2021. We are preparing for the start.Starting with the development of this AI system, we are developing AI medical devices that utilize the latest technology, and are working to contribute to improving the quality of medical care, such as digitizing and improving the efficiency of medical care and reducing the burden on medical staff. I will come.

* "Kyowa Yakuhin and FRONTEO conclude a partnership agreement regarding the development and sale of new medical devices that utilize AI to support dementia diagnosis" (announced in June 2020)
https://www.fronteo.com/20200603

■FRONTEOabout　URL: https://www.fronteo.com/

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 its business globally to Japan, the United States, South Korea, and Taiwan, focusing on legal tech businesses such as "e-discovery (electronic discovery)" and "digital forensic investigation" that support international litigation of companies. It 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).