Endoscopy AI System by AI Medical Gets Thai FDA Nod

AI MEDICAL SERVICE INC., 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 represents 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 work 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. Gastric cancer is characterized by a mortality rate that increases significantly as the disease progresses. However, if gastric cancer is detected in its early stages, it is often treatable; the 5-year relative survival rate for patients with stage 1 gastric cancer is approximately 95%, while the survival rate for patients with stage 3 and later is less than 50% . Despite this, early-stage gastric cancer is difficult to detect, and according to statistics, the missed diagnosis rate is as high as 4.5% to 25.8%.

Gastric cancer mortality remains high in Thailand (approximately 75%  of diagnosed patients die from the disease), reflecting 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 continues to experience economic growth and rising life expectancy. For example, life expectancy in Thailand is currently around 76 years7, making it one of the fastest aging populations in the ASEAN region. According to the United Nations World Population Prospects 2024, Thailand’s population has peaked and is expected to decline in the future. Therefore, as the population ages, the need for effective cancer prevention and treatment, including gastric cancer, is expected to increase. 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.

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About the AI for gastric cancer differentiation “Endoscopic image diagnosis support software – gastroAI-model G”

The brand name of the AI for gastric cancer differentiation is “Endoscopic image diagnosis support software – gastroAI-model G”, which is a diagnostic support system used to determine whether gastric lesions are neoplastic or non-neoplastic. The system analyzes static endoscopic images obtained during endoscopic examinations and provides doctors with almost instant feedback. The software will prompt that suspected lesions in the image may be neoplastic (“adenoma or adenocarcinoma”), may be non-neoplastic, or are unlikely to be neoplastic (“low confidence”). 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 mark the location of the lesion.

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