AIDOT, a company that develops medical AI solutions, said it is developing and conducting clinical trials for BIO dot AI, an AI diagnostic-support solution designed to diagnose and predict chronic liver disease.
The company said that if BIO dot AI receives approval from Korea’s Ministry of Food and Drug Safety (MFDS), it could be offered not only to patients with alcoholic liver disease but also to general screening and outpatient visitors, helping lower the cost of liver screening and enabling faster, simpler checks.
AIDOT added that since its establishment in 2014, it has received multiple awards—including recognitions from the Ministry of Science and ICT and a Prime Minister’s commendation—and has been selected for programs such as K-Global 300 and export-promising company designations.
AIDOT also described its broader portfolio, stating it has developed AI diagnostic-support software across multiple areas, including cerebral aneurysm, carotid ultrasound, gastroscopy, colonoscopy, thyroid cancer recurrence prediction, otitis media/laryngitis, urinary stones, microbiome-based liver disease, and cervical cancer.
Regarding its cervical cancer solution Cerviray AI, the article notes that AIDOT has obtained approvals including MFDS Class III medical device approval in Korea and U.S. FDA 510(k) clearance, and has completed local approvals and is expanding in markets such as Vietnam, Indonesia, Bolivia, Uzbekistan, Serbia, and Mongolia.
The company said it is currently running MFDS clinical trials for five products, and if approvals are completed in the first half of 2024, it plans to expand into domestic and global markets with a wider range of products.
Developing BIO dot AI for Chronic Liver Disease Diagnosis & Prediction
AIDOT said it participated in the Gangwon Precision Medicine Industry Regulatory-Free Special Zone project, carrying out an R&D and demonstration program to develop a precision-medicine AI solution for diagnosing and predicting chronic (alcoholic) liver disease.
According to the article, the project aims to develop AI that can diagnose liver disease and predict progression or support management by using health checkup data, clinical data, and genomic data, with partners including Sopoong & Company and Hallym University Chuncheon Sacred Heart Hospital.
AIDOT said it utilized 7,600 cases of data from the hospital, including microbiome and stool (human-derived) samples and clinical information, to develop BIO dot AI, emphasizing that it can support diagnosis without requiring a liver biopsy, thereby avoiding severe side effects such as those associated with invasive procedures and enabling diagnosis without pain.
The article states that BIO dot AI is currently in clinical trials, and that sensitivity and specificity results measured by an external performance evaluation organization were confirmed to be well above the project’s target metrics.
If commercialized, the article projects that compared with a liver biopsy, it could reduce costs by about KRW 400,000, and compared with CT/MRI, by about KRW 200,000—and could enable personalized medical services that consider complex environmental factors such as an individual’s lifestyle patterns.
Regulatory Exemptions and Data Use Enabled Development
The article explains that to develop this solution, AIDOT needed to use stool and other data collected by the hospital for research purposes, but that there was no legal basis to use the data for industrial R&D without re-consenting the data subjects.
It adds that Gangwon Technopark, which operated the special-zone program, requested a regulatory exemption from the Ministry of Health and Welfare to allow data use—without re-consent—through a secure “Data Safe Zone” installed at Douzone Bizon, and received a conditional approval. Based on this, AIDOT secured project funding and proceeded with development, and is now conducting clinical trials as part of its effort to obtain MFDS medical device approval for BIO dot AI.
The article also reiterates that AIDOT’s flagship AI medical-device software is Cerviray AI, a cervical cancer AI diagnostic-support solution built around the VIA (Visual Inspection with Acetic Acid) method, aiming to provide screening that can be performed more simply and at lower cost in settings without expensive infrastructure or specialist staffing. It describes Cerviray AI as a portable system that captures cervical images, provides AI analysis quickly on-site, and—when needed—supports remote specialist review.
CEO Jung Jae-hoon was quoted as saying that Cerviray AI is valuable because it can help provide women who cannot access cervical cancer screening due to high costs or poor medical environments with an opportunity for a healthier life.
October 18, 2023 / Financial News / Reporter Kim Ki-seop
