On November 4, 2022, a software jointly developed by the Department of Clinical Laboratory of PUMCH and Beijing Xiaoying Technology Co., Ltd. to aid the recognition of leukocytes in peripheral blood cell image was granted the first Class III AI medical device registration certificate in the IVD industry in China by the National Medical Products Administration. This not only marks the successful application of AI technology in clinical laboratory in our country, but also represents a breakthrough in the application of AI technology under new scenarios and shows China’s leading position in this field globally.

At the moment, peripheral blood cell morphology examination still relies on manual microscopy. The training of qualified clinical laboratory scientists in morphological examination is quite difficult as it is highly intensive and takes a long time, and one needs to accumulate many years’ experience and knowledge before he or she can be qualified. Thus, the traditional manual microscopy model cannot meet the growing clinical needs. Over the past five years, the Department of Clinical Laboratory of PUMCH and Beijing Xiaoying Technology Co., Ltd. have been dedicated to the research and commercialization of their scientific findings in AI-based morphological examination. Despite the challenge of screening and labeling massive data, the scientists of the clinical laboratory of PUMCH have cross-labeled and repeatedly verified each cell to ensure the high-quality output of data. This also lays a solid foundation for the security and effectiveness of software-aided recognition of leukocytes in peripheral blood cell image.

The issuance of the first Class III AI medical device registration certificate marks the successful launch of this product. This recognition software is developed based on the work experience and standards of PUMCH clinical laboratory scientists in peripheral blood cell morphology. It can improve the morphological examination of peripheral blood cell by alleviating the shortage of highly competent technicians in primary medical institutions, and at the same time enhance the examination efficiency of large medical institutions, which is of great significance to promoting the high-quality development of morphological examination. This is a scientific and technological achievement that integrates various disciplines such as diagnostic test, cell morphology, and AI-based deep learning.

Written by: The Department of Clinical Laboratory

Translator: Liu Haiyan

Editor: Zhao Ying and Wang Yao