Source: Department of Artificial Intelligence and Big Data, ZOC 

Written by: Xiaoman Huang, Department of Artificial Intelligence and Big Data, ZOC

Proofread by: Jiawei Wang 

Edited by: Xianjing Wei 

On August 10, 2020, the National Medical Products Administration officially announced that the National Key Research and Development Program of China (No.2018YFC0116500) “Development and clinical trials of artificial intelligence screening and diagnosis systems for common blinding, teratogenic, and fatal diseases,” led by Professor Haotian Lin from Zhongshan Ophthalmic Center, Sun Yat-sen University, has developed the fundus image-aided diagnostic software for diabetic retinopathy with partner Airdoc, which was approved for listing on August 7. It has part of the first batch of AI-assisted fundus diagnostic software approved for listing in China. It is an innovative medical product of National Medical Products Administration, and the first domestic product of its kind to be registered and marketed in China. To date, there is only one other comparable product worldwide (in the United States). The performance indicators and application scope of the newly developed product demonstrate significant advancements over existing technology. In 2018, The National Key R&D Program of China (No.2018YFC0116500) was launched in Guangzhou. This photo shows participants and experts who attended the conference.

The successful approval of this product is an important achievement under the strong leadership and support of the Party and our country. A series of documents were issued including the State Council's Report on Printing and Distributing the New Generation of Artificial Intelligence in 2016-2020, Opinions of the General Office of the State Council on Promoting the Development of "Internet + Medical Health", "Thirteenth Five-Year" National Eye Health Plan (2016-2020), Review Points of Medical Devices Assisted by Deep Learning and Decision-making, and the Guiding Principles for the technical review of medical devices (the second edition of the draft for comments), which provided policy guidance for the research and application of the AI in the fields of medical and health and other livelihood areas, and promoted the healthy development of the intelligent medical industry.  

In addition to the joint efforts of experts and members of the research group of national key R&D projects, the R&D and approval of the product was supported by a number of industry experts. A research team led by Prof. Wenbin Wei , Vice President of Beijing Tongren Hospital, Prof. Zhaohui Li, Director of the Department of Ophthalmology, General Hospital of Chinese PLA and Prof. Yuntao Hu, Director of the Department of Ophthalmology of Tsinghua Changgeng Hospital worked together to complete the clinical trial of the product. The expert teams of Shanghai Five Senses Hospital, Wenzhou Ophthalmology Hospital, Shanghai Changzheng Hospital and Prof. Chen Jili of Shibei Hospital have all provided strong guidance and support and have contributed to the real world research, and we would like to acknowledge them for their contribution. 

The product can accurately detect patients with diabetic retinopathy through fundus images, including early-stage mild cases. Early detection and early treatment will potentially save more diabetic patients' vision, and in the long run it can improve the overall quality of life of the whole people, and while relieving the strain on the social medical resources caused by complications.