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On 9th of August, AIDOT announced that Cerviray, an artificial intelligence cervical cancer screening solution, has been approved for clinical trial as a class 3 medical image detection software by the Ministry of Food and Drug Safety.

Following the approval of this clinical trial plan, a full-fledged clinical trial will be conducted with Professor Jae-yoon Song's team at Korea University Anam Hospital and Professor 

Sung-min Kim's team at Ilsan Cha Hospital.

Min-chan Park, Director of the Research Center said, "The device 'Cerviray' from AIDOT, unlike other AI imaging solutions in Korea, not only the▲ Classification of simple normal, 

atypical, low-grade, and high-grade lesions or ▲ white epithelium, mosaic, or atypical vascular recognition, but also it synthesized the texture, shape, and location of different lesions 

of each patient. Also, through standardization technology, it has been upgraded to a segmented reading model that meets the standards of the WHO health organization."

He added, “Especially, in the case of low-grade lesions, even small lesions that are highly likely to be missed by the naked eye, artificial intelligence detects the location within a 3% 

margin of error, and even based on these small lesions, the actual clinical faculty has transplanted the diagnostic process to AI based on decades of experience, and this clinical trial 

statistical procedure will be the only artificial intelligence-based image reading clinical trial in Korea.”

In addition, Min-chan Park, director of the research institute said, "By defining the clinical statistics process at the level of global competitiveness, we predicted that the reliability 

would be further strengthened not only in Korea but also abroad."

He also said “AIDOT has already secured not only international standard certifications such as ISO13485 and ISO9001, but also European CE certifications. Once the domestic 

Ministry of Food and Drug Safety certification is completed, it can provide public confidence to countries that require clinical results from the Ministry of Food and Drug Safety. It is 

 also verified in the certification process of Japan, North America, and European countries, which are under discussion, so now AIDOT is planning to complete entry into the global 

market immediately.”

Young-mook Jung, director of the Korea KCL Medical Foundation, also a strategic investor and partner of AIDOT, said, “Cerviray have already confirmed the usability and effectiveness of local obstetrics and gynecology clinics in Korea, and will be sequentially supplied to hospitals that have expressed their intention to introduce it when the domestic Ministry of Food and Drug Safety certification is completed. This will be an excellent opportunity for both hospitals and patients to win in terms of spreading artificial intelligence medical devices to 

primary and secondary hospitals in Korea."

Reporter Dae-hyun Lee of Medical Today (dleogus1019@mdtoday.co.kr)