AIDOT (CEO Jeong Jae-hoon) announced that its AI-based pre-screening stroke solution using carotid ultrasound imaging has received clinical trial plan approval from the MFDS under the category of “cardiovascular image detection and diagnostic support software.”
AIDOT’s carotid ultrasound-based AI stroke pre-screening solution, SONO dot AI, supports clinicians’ diagnostic decisions by detecting the presence of carotid plaque and analyzing the likelihood that detected plaque may lead to ischemic stroke. The solution was developed together with a team led by Professor Jeon Jin-pyeong of the Department of Neurosurgery at Hallym University Chuncheon Sacred Heart Hospital. It classifies carotid plaque into three categories—normal, low-risk, and high-risk—and, according to internal evaluation results, achieved 87.5% sensitivity and 85% specificity. The company also stated that it has completed patent registration for an accuracy of 99% in automatic cross-sectional plane classification.
Im Yoon-jae, head of AIDOT’s Business Planning Division who oversees regulatory affairs (RA), said, “This clinical trial will confirm the performance and clinical validity of an algorithm created by training AI to learn the location and instability of plaque present in the carotid artery. In particular, SONO dot AI indicates not only instability analysis results but also the plaque’s location, making it effective as supporting data for treatment. By reducing differences between test results from inexperienced examiners and experienced examiners, it will become a highly necessary medical solution not only for countries with insufficient medical infrastructure but also for developed countries where the family doctor system is well established.”
Stroke is a disease in which blood vessels in the brain become blocked (cerebral infarction) or rupture (cerebral hemorrhage), and when it occurs, it can lead to severe aftereffects such as impairments in motor, language, and cognitive functions. AIDOT said it expects this solution to help reduce substantial social and economic losses by moving beyond the existing approach focused on treatment after stroke onset and instead enabling pre-screening. The company also explained that in carotid plaque testing, ultrasound has advantages such as relatively short exam time, low cost, and repeatability, and that because non-experts can have difficulty performing the exam and interpreting vulnerable carotid plaque, the AI helps even inexperienced users interpret carotid ultrasound results more easily.
Im Ga-ram, head of Global Sales & Marketing at AIDOT, said, “There have already been many inquiries from overseas since the development stage for this Sono dot AI solution, and substantial contract discussions have already taken place with existing clients regarding distribution of the solution.” She added, “We will successfully complete this clinical trial, expedite overseas regulatory approvals, and create an overseas success story that follows Cerviray AI.”
Published: November 3, 2022 / Korea Data Economy News / Reporter Lee Sae-yeon
