AIDOT receives clinical trial plan approval from Korea MFDS for AI stroke solution based on carotid ultrasound images

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Date 2022-11-08

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The product 'Sono dot AI'

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AIDOT (CEO Jae-hoon Jeong) announced that its carotid artery ultrasound image-based artificial intelligence stroke pre-screening solution has been approved by the Ministry of Food and Drug Safety for a clinical trial plan as a ‘cardiovascular image detection/diagnosis auxiliary software’ item.


AIDOT's carotid ultrasound-based artificial intelligence stroke pre-screening solution (Sono dot AI) assists medical staff in making diagnosis decisions by detecting the presence of 

carotid ultrasound-based plaque and analyzing the possibility of ischemic stroke with the detected plaque. It was developed together with Professor 'Jin-pyeong Jeon's medical team 

at the Department of Neurosurgery at Sacred Heart Hospital. Carotid artery plaques are classified into 3 categories: normal, low-risk, and high-risk. As a result of self-assessment, it 

achieved 87.5% of sensitivity and 85% of specificity.


“This clinical trial will learn about the location and instability of plaques in the carotid artery using artificial intelligence, and will confirm the performance and clinical effectiveness of 

the algorithm created in this way,” said Yoon-jae Lim, head of Business Planning Headquarters, who handls Aidot's overall RA. In particular, Sono dot AI can be effectively used as 

evidence data for treatment in that it displays not only the results of instability analysis but also the location of plaques. This will reduce the difference between test results by 

unskilled inspectors and those by skilled inspectors, and will be a very necessary medical solution not only in countries with insufficient medical infrastructure, but also in developed 

countries where Family Doctors are active.”


Stroke is a disease in which blood vessels in the brain are blocked (cerebral infarction) or burst (cerebral hemorrhage). However, AIDOT expects that this solution will be able to 

reduce enormous social and economic losses by screening in advance, moving away from the existing form of focusing on treatment after the onset of stroke. In addition, in the 

carotid artery plaque examination, ultrasound scan has the advantage of relatively short examination time and low cost, as well as being able to perform repeated examinations. It 

assisted the unskilled person to easily read the results of carotid artery ultrasonography.


Garam Lim, Head of Global Sales and Marketing at AIDOT, said, “There have already been many inquiries from overseas about the Sono dot AI solution from the development stage, 

and contract discussions have already been made with existing customers about the distribution of the solution.” additionally, she expressed her ambition, saying, "We will 

successfully complete this clinical trial, speed up the overseas licensing process, and create an overseas success story following Cerviray AI."


03rd Nov. 2022. / Korea Data Economy Newspaper / Reporter Sae-yeon Lee

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