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AIDOT "Cerviray A.I." receives KFDA Class III Medical Device Approval

Posted by aidot(ip:)

Date 2022-06-10

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Cerviray AI is used in the VIA (Visual Inspection with Acetic-acid) method

    

    

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On 9th of June, AIDOT (CEO Jae-hoon Jeong) announced that Cerviray A.I., an artificial intelligence software for cervical cancer screening, has been approved as a Class 3 medical 

device by the Korean Ministry of Food and Drug Safety (KFDA).

 

In March 2021, AIDOT received permission from the Ministry of Food and Drug Safety for its in vitro medical camera ‘Cerviray Hardware’, and this time, with the completion of the 

Cerviray A.I. software license, it is expected to speed up its entry into the global market.

 

Artificial intelligence software Cerviray A.I. utilizes patient data captured by Cerviray hardware to automatically display the possibility of disease, severity, or disease state. The results analyzed by the artificial intelligence server are immediately delivered to the medical team as auxiliary data so the medical staff can quickly make the necessary diagnosis.

 

AIDOT conducted a clinical trial of artificial intelligence-based cervical imaging diagnostic aid software (Cerviray A.I.) with Korea University Anam Hospital earlier this year to obtain 

software license approval. Through this clinical trial, which was conducted after a precise test setting, it was confirmed that AIDOT's Cerviray A.I. is a clinically effective medical 

device.

 

Cerviray A.I. can be used anywhere as long as it has hardware for photographying, software inside the device, and an Internet environment to access artificial intelligence servers. In 

addition, while existing prosecutors require high-cost infrastructure such as professional manpower and research laboratories, it has the advantage of being able to build 

infrastructure at a low cost.

 

Yoon-jae Lim, head of Business Planning Headquarters, who handles AIDOT's overall RA said, “Cerviray A.I is receiving love calls from countries around the world, including Indonesia, where commercialization has already been confirmed, as well as Philippines, Uzbekistan, Vietnam, and Thailand. This approval from the Ministry of Food and Drug Safety will be an 

important opportunity to accelerate software approval abroad, and it will advance the day when cervical cancer screening services through Cerviray A.I are widely used in the global 

market.”

 

Overview of AIDOT Inc.

 

Since its foundation in June 2014, AIDOT has been recognized for its technological prowess, including being selected for KIC China and various government projects. In addition, an 

artificial intelligence-based reading system combining carotid ultrasound and genomic information was jointly developed with Hallym University Chuncheon Sacred Heart Hospital's 

Department of Neurosurgery, and a digestive AI diagnosis system that integrated gastroscopy, capsule endoscopy, and colonoscopy was also completed.

Southeast Asian markets.

 

10th. Jun. 2022. / News Digest



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