DIABETIC retinopathy analysis software produced by a Shenzhen-based company has been approved as an innovative medical device by the National Medical Products Administration and entered the stage of clinical trials and expedited review, according to the city’s market regulator.

The software, designed by Shenzhen Guiji Intelligent Technology Co. Ltd., will likely become China’s first artificial intelligence (AI) medical product approved by the national authority, the Shenzhen Special Zone Daily reported yesterday.

Diabetic retinopathy, a common cause of poor vision and blindness among adults suffering from diabetes, requires early detection to prevent its exacerbation.

Many patients with diabetes are not adequately informed about the disease, thereby delaying their diagnosis and causing them to lose their vision, the report said.

In recent years, the application of AI in the medical field has been considered the most feasible and practical development direction at the current stage. On April 11, 2018, the Food and Drug Administration of the United States approved IDx-DR, the world’s first medical device to utilize AI technology to detect diabetic retinopathy.

The software developed by the Shenzhen company has similar applications to its American counterpart.

However, its development requires collecting enough cases involving the physiological characteristics of Chinese people, establishing independent mathematical models and core algorithms, incorporating the unique learning ability of AI into clinical practice and passing the review. The whole process can only be developed independently by the Shenzhen company.

According to Shenzhen Municipal Market Supervision Administration, the software has an innovative design scheme and mature technology, which makes it the favorite to become the first AI medical product approved for market registration. It also marks a milestone in the history of China’s medical development by utilizing AI.

According to the Daily, as of May 31 this year, 26 of the 225 innovative medical devices approved by the National Medical Products Administration had come from Shenzhen.

The figure is third only to Beijing and Shanghai, and accounts for more than 70 percent of the total number of such products from Guangdong Province.

(Liu Wenjin)