Yitu Healthcare Secures China's First NMPA Class III Certification for AI-Powered Pediatric Bone Age Assessment Software

On March 19, the National Medical Products Administration (NMPA) officially approved the Class III medical device registration application for Hangzhou Yitu Healthcare Technology Co., Ltd.’s “AI-Assisted Bone Age Assessment Software for Pediatric Hand X-ray Images.” This marks the first Class III certification granted to a pediatric bone age AI product in China, making this system the only pediatric bone age AI solution currently approved with a Class III medical device license.

The review report issued by the Center for Medical Device Evaluation of the National Medical Products Administration indicates that the mean absolute error between the TW3-RUS and TW3-Carpal bone age diagnostic results of the investigational device and those of the gold standard met the predefined objectives. Meanwhile, the software’s ease of use and system stability were both rated as satisfactory. No adverse events or device deficiencies occurred during the clinical trial.

Since the launch of its first AI-powered bone age assessment product in 2017, care.ai®Rapid Iteration of the AI-Assisted Pediatric Bone Age Assessment System, it is the first globally to support multiple bone age assessment standards, including TW3, CHN-05, and the GP Atlas method, achieving industry-leading performance across all these frameworks and fully meeting the needs for intelligent bone age diagnosis in diverse scenarios. Meanwhile, leveraging a comprehensive product portfolio,To address the comprehensive needs of pediatric growth and development specialties, we provide services ranging fromSupport for a full-course growth and development solution encompassing “screening, doctor-patient communication, diagnosis, treatment, and follow-up,”Established an Intelligent Diagnosis and Treatment Service Platform for Children's Growth and Development, supporting healthy growth in children.

Children are the hope and future of the nation. The Outline of the 14th Five-Year Plan for National Economic and Social Development of the People’s Republic of China and the Long-Range Objectives Through the Year 2035 (hereinafter referred to as the “14th Five-Year Plan”) explicitly states: “We should further improve the level of care and services for minors, enhance the child health service system, prevent and control childhood diseases, and effectively curb childhood obesity and myopia.”

During the 2021 “Two Sessions,” numerous renowned pediatric experts jointly called for attention to the fact that China’s population under the age of 14 has reached 248 million, emphasizing that safeguarding children’s healthy growth is of significant national importance. The epidemiological trend of pediatric diseases is shifting from traditional infectious and malnutrition-related conditions to genetic and metabolic disorders, such as obesity, precocious puberty, and growth and developmental impairments, underscoring the urgent need to establish a comprehensive health evaluation system for children’s growth and development.

Experts unanimously agree that children’s growth and development status serves as a critical indicator of systemic health. Growth and developmental disorders, such as obesity, short stature, and precocious puberty, can directly impair patients’ physical and psychological well-being, with far-reaching consequences for their future academic performance, career prospects, and marital life. In response to the public’s rising expectations for child-rearing and the surge in second-child births, the proactive application of advanced technologies, such as artificial intelligence (AI) and big data, to refine key indicators and assessment systems for pediatric growth and development in China holds substantial clinical and social value.

Bone age is a critical indicator for assessing the growth and development of adolescents. Compared with metrics such as height and weight, it more accurately reflects the actual developmental status of the human body. However, for a long time, the clinical application and follow-up of bone age assessment have been severely limited by factors including a shortage of highly skilled pediatricians, low efficiency in image interpretation, and poor inter-rater consistency.

Powered by Advanced AI Technology, care.ai®Intelligent Auxiliary Assessment System for Children's Bone Age Implements Multiple Bone Age StandardsSecond-level precision in bone age assessment significantly enhances efficiency, accuracy, and consistency, addressing three major clinical challenges simultaneously. It also generates comprehensive pediatric growth and development reports within seconds by integrating multidimensional data, thereby providing clinicians with more robust decision support.

Over the years, YITU Medical has steadily advanced the construction of an evidence-based medicine chain for AI-based bone age assessment. By collaborating closely with dozens of renowned pediatric hospitals across multiple cities in China, it has completed a series of performance studies on AI-based bone age assessment using real-world data. Multiple research findings have been accepted by international journals and conferences, laying a solid foundation of evidence-based medical evidence for the regulatory approval of AI systems for pediatric bone age assessment.

In the study titled “Diagnostic performance of convolutional neural network-based Tanner-Whitehouse 3 bone age assessment system,” Yitu Medical, in collaboration with Professor Fu Junfen’s team—where Professor Fu serves as the Head of the Endocrinology, Genetics, and Metabolism Group under the Pediatric Branch of the Chinese Medical Association and as Executive Vice President of the Children’s Hospital Affiliated to Zhejiang University School of Medicine—conducted a comprehensive and in-depth quantitative analysis of the real-world clinical performance of an AI-based bone age assessment system, evaluating metrics such as image reading time, accuracy, and consistency.

In the study titled “Artificial intelligence system can achieve comparable results to experts for bone age assessment of Chinese children with abnormal growth and development,” Yitu Medical, in collaboration with Peking Union Medical College, the Department of Radiology, and the Department of Endocrinology at Peking Union Medical College Hospital, conducted an in-depth investigation into the performance reliability of a bone age AI system when interpreting bone age images of children with abnormal growth and development. The study was guided by Professor Jin Zhengyu, then Chairman of the Chinese Society of Radiology of the Chinese Medical Association and Director of the Department of Radiology at Peking Union Medical College Hospital.

In another study titled “Performance of an artificial intelligence system for bone age assessment in Tibet,” YITU Medical once again partnered with Peking Union Medical College Hospital to reach the border regions of Tibet, leveraging AI technology to facilitate bone age assessment for children in the area. The collaboration further investigated the distinct characteristics of growth and development among children in remote areas and explored the feasibility of establishing region-specific bone age interpretation models.

The aforementioned studies all indicate that YITU Medical’s AI-based intelligent bone age assessment offers numerous advantages, including rapid processing, high accuracy, and strong consistency. It significantly saves hospital manpower and material resources, and is crucial for conducting large-scale, regular screenings within regions, accurately monitoring children’s growth and development, and promoting the establishment of national standards for child growth and development in China.

Children are the hope and future of the nation. Issues concerning children’s growth and development bear on the healthy growth of every child in China and on the well-being and happiness of every family.YITU Medical is committed to safeguarding the nation’s future with AI, continuously protecting health through data intelligence, and enabling universal access to better healthcare through technological innovation.