TOKYO -- AI MEDICAL SERVICE INC. (hereinafter AIM), a medical start-up specializing in the development of diagnostic endoscopic AI, announced that it has received medical device approval from the Thai Food and Drug Administration (Thai FDA) on June 26, 2025. The approval is for its endoscopic image diagnosis support software, the “gastroAI-model G.” This system utilizes artificial intelligence to assist physicians in differentiating between neoplastic and non-neoplastic gastric lesions within endoscopic images. This marks the first time in Thailand that an AI-powered diagnostic support system for the upper gastrointestinal tract, equipped with lesion differentiation[1] capabilities, has received regulatory approval[2].

Background of our efforts to complete regulatory review and device registration in Thai
Gastric cancer is the fifth most common cancer in the world, with more than 1 million people contracting gastric cancer and approximately 600,000 people dying from the disease each year[3]. Gastric cancer is characterized by a mortality rate that increases significantly with disease progression. However, gastric cancer is very often treatable if detected at an early stage; the 5-year relative survival rate is approximately 95% if detected at stage I, but less than 50% if detected at stage III or later[4]. Nevertheless, early-stage gastric cancer is difficult to detect and is said to be missed in 4.5 to 25.8% of cases[5].

In Thailand, the high mortality rate for gastric cancer (approximately 75%[6] of diagnosed individuals die from the disease) suggests that many cases are detected at an advanced stage. This healthcare challenge is compounded by significant demographic trends; as a member of the Global South, Thailand is experiencing economic growth and a rising life expectancy. For example, the current average life expectancy of around 76 years[7] is one factor that contributes to Thailand having one of the most rapidly 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. Consequently, the need for effective cancer countermeasures, including for gastric cancer, is expected to rise concurrent to aging demographics. By delivering our gastric cancer diagnostic support AI leveraging Japan's world-leading endoscopic medical technology to the clinical frontline in Thailand, we aim to address the anticipated shortage of endoscopy specialists and ultimately contribute to reducing the number of deaths from gastric cancer.