TOKYO -- AI MEDICAL SERVICE INC. (hereinafter AIM), a medical start-up specializing in the development of diagnostic endoscopic AI, is excited to announce the first instance of Singaporean regulatory review and device registration for an AI-based endoscopic diagnostic support device that operates within the stomach (brand name: Endoscopic image diagnosis support software - gastroAI-model G). The regulatory review and device registration was conducted by Singapore’s Health Sciences Authority (hereinafter HSA) on February 19, 2024. The endoscopic AI (hereinafter gastric cancer differentiation AI) differentiates gastric lesions and judges them as either neoplastic or non-neoplastic in nature. In addition, AIM has confirmed that this is the first case of device registration in Singapore for an endoscopic support software that operates within the upper gastrointestinal tract.

Background of our efforts to complete regulatory review and device registration in Singapore

Gastric cancer is the fifth most common cancer in the world, with more than 1 million people contracting gastric cancer and approximately 770,000 people dying from the disease each year. 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. Nevertheless, early-stage gastric cancer is difficult to detect and is said to be missed in 4.5 to 25.8% of cases.

In countries with a high incidence of gastric cancer like Japan and South Korea, endoscopic gastric cancer screening is routinely performed nationwide. However, such screening is not a routine practice in Singapore and other countries, further complicating the early detection of gastric cancer.

Considering these circumstances, AIM has been conducting joint research on endoscopic AI with National University Hospital of Singapore (hereinafter NUH). AIM and NUH reported that endoscopic AI can support endoscopists’ ability to diagnose and potentially find gastric cancer at an early stage[1]. In addition, through communication with local physicians and activities at academic conferences, AIM has increased awareness regarding the value that endoscopic AI can provide to clinical practice in Singapore. Concurrent to that, AIM spent years working to complete regulatory review and device registration in Singapore.

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”)[2]. 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
· Registration number : DE0508971

Future Developments

AIM has been conducting joint research with NUH, a top-ranked university in Asia. AIM will continue to develop AI products through joint research with NUH, expanding device functions and target organs in line with the challenges faced by patients practitioners in Singapore. In addition, utilizing regulatory approval in Singapore, AIM aims to obtain approval and develop our business in other ASEAN countries through “the ASEAN Medical Device Directive,” a common framework that aims to improve efficiency and simplify the application process regarding the registration of medical devices in ASEAN countries.