AI Medical Service’s AI-Powered Gastric Endoscopy System Gains Thai FDA Approval
A medical startup focused on the development of AI diagnostic technology for endoscopy, is pleased to announce that it has received medical device approval from the Thai Food and Drug Administration (Thai FDA) on June 26, 2025. The approval was for the company’s endoscopic imaging diagnostic support software “gastroAI-model G”. The system uses artificial intelligence technology to assist physicians in distinguishing between neoplastic and non-neoplastic gastric lesions in endoscopic images. This marks the first regulatory approval in Thailand for an upper gastrointestinal AI diagnostic support system with the ability to differentiate lesions12 .
Background on our regulatory review and device registration in Thailand
Gastric cancer is the fifth most common cancer in the world, with more than 1 million new cases and approximately 600,000 deaths each year 3 . Gastric cancer is characterized by a mortality rate that increases significantly as the disease progresses. However, if gastric cancer is detected at an early stage, it is often treatable; the 5-year relative survival rate for patients with stage I gastric cancer is approximately 95%, while the survival rate for patients with stage III and later is less than 50% 4 . Despite this, early gastric cancer is difficult to detect, and according to statistics, the missed diagnosis rate is as high as 4.5% to 25.8 5 .
Gastric cancer mortality remains high in Thailand (approximately 75% 6 of diagnosed patients die from the disease), indicating that many cases are diagnosed at an advanced stage. This medical challenge is also exacerbated by significant demographic trends: as a member of the Global South, Thailand’s economy continues to grow and life expectancy continues to rise. For example, life expectancy in Thailand is currently around 76 years7 , making Thailand one of the fastest aging countries in the ASEAN region. According to the United Nations’ World Population Prospects (2024), Thailand’s population has reached its peak and is expected to decline in the future. Therefore, as the population ages, the need for effective prevention and treatment of cancers, including gastric cancer, is expected to grow. By combining Japan’s world-leading endoscopic medical technology with AI to support gastric cancer diagnosis and applying it to the clinical frontline in Thailand, we aim to alleviate the expected shortage of endoscopist specialists and ultimately help reduce the number of deaths from gastric cancer.
About the AI for gastric cancer differentiation “Endoscopic imaging diagnostic support software – gastroAI-model G”
The brand name of the AI for gastric cancer differentiation is “Endoscopic imaging diagnostic support software – gastroAI-model G”, which is a diagnostic support system for determining whether gastric lesions are neoplastic or non-neoplastic. The system analyzes static endoscopic images obtained during endoscopic examinations and provides physicians with near real-time feedback. The software will indicate that suspected lesions in the image may be neoplastic (“adenoma or adenocarcinoma”), may be non-neoplastic, or are unlikely to be neoplastic (“low confidence”) 8. If the lesion in the image is neoplastic, the system will display its visual similarity (confidence) to historical neoplastic lesions and superimpose a rectangular box on the image to indicate the location of the lesion.
Brand name: Endoscopic imaging diagnostic support software – gastroAI-model G
Approval number: 68-2-2-2-0006282
About AI Medical Service Inc.
AI Medical Service is a medical technology company and healthcare startup with a mission to “save lives around the world”. Japan is a world leader in endoscopy and has accumulated world-class clinical data in both quantity and quality. We are committed to using this data to develop products and aim to quickly apply the results of our work to clinical practice, thereby saving patients around the world.
Company Information
Company name: AI Medical Service Inc.
Address: Hareza Tower 11F, 1-18-1 Higashi-ikebukuro, Toshima-ku, Tokyo 170-0013, Japan
Management: Tomohiro Tada, Yasushi Takigawa
Founded: September 1, 2017
Business scope: Development of endoscopic artificial intelligence (AI) technology to support diagnostic imaging and related activities
