BD - Earth day 2024

AI Medical Service Secures Initial Pharmaceutical Registration for Gastric AI-driven Endoscopic Diagnosis Support System from Brazil's ANVISA

Tuesday, April 23, 2024

AI Medical Service a pioneering medical startup specializing in the development of diagnostic endoscopic AI, is thrilled to announce the successful registration of its AI-based endoscopic diagnostic support device, named gastroAI (model G), with Brazil’s National Health Supervisory Agency (ANVISA) on April 1, 2024. This registration marks the first instance of pharmaceutical approval for an endoscopic support software operating within the upper gastrointestinal tract in Brazil.

GastroAI operates within the stomach and aids physicians in identifying neoplasia during endoscopy by highlighting lesion candidates for biopsy or further diagnostic steps based on visual characteristics.

Gastric cancer ranks as the fifth most prevalent cancer globally, with over 770,000 fatalities annually and more than 1 million new cases reported each year. Early detection significantly improves survival rates, with a 5-year relative survival rate of approximately 95% at stage I, compared to less than 50% at stage III or later. However, early-stage gastric cancer remains challenging to detect, contributing to missed diagnoses in a significant percentage of cases.

In Brazil, the proximity between reported cases and fatalities suggests that failures in early detection directly correlate with mortality rates. With a population exceeding 210 million and a demographic shift towards an aging population, Brazil faces an impending shortage of endoscopists, particularly in certain regions. AIM recognizes the urgent need to address these challenges by integrating AI technology into clinical practice, leveraging Japan's renowned expertise in endoscopic medical technology.

By combining cutting-edge AI with Japan's world-leading endoscopic capabilities, AIM aims to mitigate the shortage of endoscopists and reduce mortality rates associated with gastric cancer in Brazil. This milestone underscores AIM's commitment to advancing healthcare through innovative solutions and signifies a significant step forward in the fight against gastric cancer in Brazil and beyond.

Source: en.ai-ms.com