MFDS Designates Gastric Cancer Diagnostic Support Software as the 37th Innovative Medical Device

The Ministry of Food and Drug Safety announced on the 19th that it has designated the ‘Gastric Cancer Image Detection and Diagnosis Assistance Software’ as the 37th innovative medical device, which analyzes gastroscopy images to assist medical professionals in diagnosing gastric cancer.

The designated product is ‘WAYMED endo ST CS’ by WAYCEN, a company developing precision medical artificial intelligence software.

Weimed Endo of Weisen [Photo by Ministry of Food and Drug Safety]

Recognized for its technological innovation in diagnosing gastric cancer by analyzing gastroscopy images in real time using deep learning-based AI technology, it was designated as an innovative medical device.

An official from the Ministry of Food and Drug Safety stated, “This product is the first domestic software targeting gastric cancer, and it is expected to lead the expansion of the diagnostic assistance software market for gastric cancer in the future.”

The Ministry designates medical devices with advanced technologies in fields such as information and communication, biotechnology, and robotics, which have high technology intensity and rapid innovation speed, as innovative medical devices. Designated products receive support such as priority review. The Ministry expects that the operation of the innovative medical device designation system will contribute to realizing the government’s national agenda of becoming a global hub for bio and digital health.

This content was produced with the assistance of AI translation services.