Endoscopic AI: AI Medical Service Inc. Has Obtained Regulatory Approval from Thailand’s FDA for Its Gastric AI-based Endoscopic Diagnosis Support System

TOKYO--( BUSINESS WIRE )-- AI MEDICAL SERVICE INC. (hereinafter AIM), a medical start-up specializing in the development of diagnostic endoscopic AI, is excited to announce 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 differentiation¹ capabilities, has received regulatory approval².

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Software image

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 year³. 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 later⁴. Nevertheless, early-stage gastric cancer is difficult to detect and is said to be missed in 4.5 to 25.8% of cases⁵.

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 years⁷ 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.

About gastric cancer differentiation AI “Endoscopic image diagnosis support software - gastroAI-model G”
The gastric cancer differentiation AI, brand-named “Endoscopic image diagnosis support software - gastroAI-model G,” is a diagnosis support system for determining the neoplastic or non-neoplastic nature of gastric lesions. The system analyzes endoscopic still images acquired during endoscopic examination and provides near-instant feedback to the physician. The software indicates whether the candidate lesion featured in the image is likely neoplastic (“Adenoma or Adenocarcinoma”), likely non-neoplastic, or unlikely to be neoplastic (“Low Confidence”)⁸. If the lesion in the image is neoplastic, the degree of visual similarity between it and historical neoplastic lesions (confidence level) is displayed, and a rectangle indicating the location of the lesion is superimposed onto the image.

Brand name: Endoscopic image diagnosis support software - gastroAI-model G
Approval Number: 68-2-2-2-0006282

About AI Medical Service Inc.
AI Medical Service is a med-tech company and healthcare startup guided by the mission to "Save Lives All Over the World." Japan is a world leader in the field of endoscopy, with an accumulation of world-class data in both quality and quantity. We are engaged in product research and development that leverages this data, and we aim to save patients worldwide by swiftly delivering the results of these efforts to clinical settings.

Company
Company: AI Medical Service Inc.
Address: Hareza Tower 11F, 1-18-1 Higashi-ikebukuro, Toshima-ku, Tokyo 170-0013, Japan
Executive Leadership: Tomohiro Tada, Yasushi Takigawa
Founding: September 1, 2017
Business: Development of endoscopic AI (artificial intelligence) to support diagnostic imaging and related activities

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