Deepwise AI Secures Fifth NMPA Class III Certification with Pediatric Bone Age Assessment Software

Recently, Deepwise Healthcare’s AI-assisted bone age assessment software for pediatric hand X-ray images received approval for a Class III medical device certification from the National Medical Products Administration (NMPA) of China. This marks the fifth Class III certification for an AI product obtained by Deepwise Healthcare within just over a year since it secured its first NMPA Class III certificate in November 2020, making it one of the few medical artificial intelligence companies in China to hold five NMPA Class III certifications simultaneously. 

Deepwise Medical’s Class III NMPA certification for its AI-based bone age assessment product adheres to evaluation standards that are entirely different from those applied to Yitu Healthcare’s original Class III bone age certification. Following the integration of Yitu Healthcare into Deepwise Medical, both Class III certifications for bone age assessment issued by the National Medical Products Administration (NMPA) in the field of pediatric growth and development now belong to Deepwise Medical, underscoring the company’s robust technological and product capabilities in pediatrics.

This marks the fifth Class III medical device registration certificate issued by the National Medical Products Administration (NMPA) obtained by Deepwise Healthcare (including Yitu Healthcare). To date, the NMPA has issued more than 20 Class III certificates in the field of medical artificial intelligence, with Deepwise Healthcare accounting for five. This achievement strongly underscores Deepwise Healthcare’s robust capabilities and extensive expertise in technological innovation and product development. In the realms of medical imaging and healthcare big data, Deepwise Healthcare boasts a comprehensive portfolio of AI-powered products. The company has published nearly 300 research papers in prestigious international academic journals such as Science, Nature, Medical Image Analysis (MIA), and IEEE Transactions on Pattern Analysis and Machine Intelligence (TPAMI), which demonstrate both clinical value and technological innovation. It holds nearly 700 software copyrights and patents, with a cumulative impact factor exceeding 800. Furthermore, the company has undertaken nearly 40 major special research projects funded by the Ministry of Science and Technology, the National Natural Science Foundation of China (NSFC), and provincial and municipal governments across China. In 2021 alone, it successfully secured four NSFC projects through joint applications with multiple domestic medical institutions and was awarded the Second Prize of the National Science and Technology Progress Award.

In recent years, emerging technologies such as 5G, big data, and artificial intelligence have ushered in a new wave of applications across medical devices, equipment, and the healthcare industry at large. The field of medical imaging, in particular, has been leveraging technological advancements to continuously reshape public understanding. As one of the rapidly growing medical AI companies in the past two years, Deepwise Medical has consistently upheld a spirit of continuous innovation, forging ahead with determination while refining its products to enhance clinical utility. Looking forward, we are confident that artificial intelligence will drive even greater technological breakthroughs and significant leaps in the healthcare sector.