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Buzzpole (CEO Jae-hoon Jeong), a leader in artificial intelligence medical ICT, announced that it had been officially approved for manufacturing KFDA class 3 medical devices for 

export for the first time in Korea in relation to 'Cerviray AI', an artificial intelligence reading system for cervical cancer developed by itself.

The company has significantly improved the objectivity of the test by combining the limitations of the existing visual identification with artificial intelligence with VIA (Visual 

Inspection with Acetic acid) colposcopy in the cervical cancer diagnosis method. After years of joint research, the results came to fruition.

ProfessorJae-yoon Song of the Department of Obstetrics and Gynecology at Korea University Anam Hospital said, “The Cerviray AI test method can be very effective in countries 

where cytology or HPV testing is practically impossible, as well as in countries with a large area or relatively low medical benefits. Also for cervical cancer screening, which requires 

regular checkups even in developed countries, artificial intelligence-based colposcopy can increase the probability of diagnosis, which is very efficient point.”

Korea University Medical Center’s Industry-University Cooperation Foundation said that by entering into a full-fledged cooperation contract to participate in clinical consultation 

according to artificial intelligence cervical cancer screening that occurs overseas, it is very positive in terms of business model expansion as well as contributing to global women's 

health in terms of joint overseas expansion and securing additional profit models.

'CervirayAI', which is ready for export through the approval of the Ministry of Food and Drug Safety, has completed registration of major patents and completed registration of more 

than 22 domestic and foreign additional patents and trademarks, and has secured more than 90% artificial intelligence sensitivity from international software quality inspection 

institutions. 

Based on this, ISO13485 certification will be completed in March and European CE MDR certification will be completed in early May for the first time in Korea. It is a certification that 

is essentially differentiated from the European CE MDD certification certified by existing companies, which expires in May this year, and plans to prove higher public confidence 

through this certification.

Buzzpole CEO Jae-hoonJeong emphasized that “It is not a mechanical algorithm that simply detects abnormal images at high speed, but an algorithm developed with expert knowledge and verified data obtained clinical permission through university hospitals based on clinical standards applied to colposcopy around the world. In particular, it is an artificial 

intelligence-based examination assistant solution that can be trusted and utilized by all medical personnel around the world, such as nurses and midwives who can perform 

colposcopy (in the case of overseas), as it is designed by learning the diagnosis method performed by experts.”

In addition, It is said that Buzzpole also did business with China, a major target country. When China was in a very difficult situation due to COVID 19, Buzzpole obtained medical 

protective clothing on its own and exported more than 400 million won to the Wuhan region and the Hunan Province government, further strengthening relations with Chinese 

investors and Chinese government officials.

Won-joon Park, head of marketing at Buzzpole, said, “Exports will be carried out simultaneously not only to China, but also to Southeast Asian, European and American markets. It has already been steadily progressing with companies that want to cooperate and introduce it, and based on this certification, full-scale export negotiations have begun. In particular, 

as FDA certification is expected to be granted with a difference of 2 to 3 months in addition to European CE MDR certification, a situation has been prepared for Buzzpole's artificial 

intelligence technology to be globally recognized and enter the market.”

Along with Cerviray AI products, Buzzpole also has stroke-related artificial intelligence medical solution being jointly developed with Hallym Chuncheon Sacred Heart Hospital. 

It expects sales of more than 10 billion won this year alone and it will sound an alarm bell as a best practice in the AI diagnosis market.

As part of this, it is reported that Buzzpole will participate in the International Medical Equipment and Hospital Equipment Exhibition (KIMES) next month along with the Korea 

University Medical Center Industry-University Cooperation Foundation and invite foreign partners that have been in cooperative relationships to proceed with export work in earnest.

Reporter So-hee Kang webmaster@kmdia.or.kr

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