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On 2nd of September, AIDOT, an artificial intelligence-based medical ICT company, has obtained certification for compliance with the class 3 medical device manufacturing and quality control standards (GMP) for its artificial intelligence-based cervical cancer reading system 'Cerviray AI' as a Physiological Monitoring Device item group.
GMP (Good Manufacturing Practice) is a quality assurance system managed by the Ministry of Food and Drug Safety to ensure that medical device manufacturers can consistently
produce them with quality suitable for their intended use by confirming the safety and effectiveness of medical devices produced by them. Cerviray AI has been certified as ‘Medical
Image Assistant Diagnostic Software’.
Medical image assistant diagnosis software is software that helps medical personnel make diagnosis decisions by automatically displaying the△possibility and degree of disease,
△severity, and △condition through medical images.
AIDOT plans to promote the class 3 certification of the Ministry of Food and Drug Safety as AI-based medical image assistant diagnosis software for other solutions that have been
developed, such as an AI-based stroke reading system.
AIDOT has completed the European CE and China Food and Drug Administration (CFDA) certification procedures with overseas partners for overseas commercialization, and through
this, it is actively exporting in China, Europe, and Southeast Asia.
AIDOT said that it has completed all preparations for certification by the Ministry of Food and Drug Safety, including domestic clinical trial procedures, for reverse entry into the
country in early 2021, and that it is conducting in-depth preliminary discussions with several domestic partner companies.
Deok-yeol Kim, head of the development department said that “We have established a win-win business model with domestic medical staff, and we hope that diagnostic aid software will be of great help to both doctors, patients and companies in not only the domestic cervical cancer diagnosis market but also the stroke diagnosis market.”
[Chosun Biz / Reporter Yoon-sun Jang]
02nd. Sep. 2020. 10:08
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