Breakthrough! China's NMPA Grants First-Ever Class III Certificate for Breast AI Product to Deepwise Medical – Its Sixth Certification

Recently, DeepWise Medical’s breast AI software received Class III medical device certification from China’s National Medical Products Administration (NMPA). This is the first and currently the only Class III certification for breast AI issued by the NMPA in China. With this approval, DeepWise Medical has now accumulated a total of six NMPA Class III certifications, expanding the application of artificial intelligence into a new field.

Deepwise Medical’s AI product, which has received China’s first Class III NMPA certification for breast imaging, consists of software installation packages including a web-based client and a server-side component. The web client comprises modules for task creation, communication and data transmission, data overview, image viewing and processing, deep learning-based automatic detection of breast lesions, breast lesion annotation, BI-RADS classification, and integrated text-and-image reporting. The server side includes modules for the homepage, service management, operation monitoring, user management, and system configuration. Developed in conjunction with clinical prior knowledge, this product is primarily applied to breast cancer screening and auxiliary diagnosis. Meanwhile, the structured detection information provided by the system lays the foundation for building specialized disease databases and facilitating further scientific research applications.

The incidence of breast cancer in China is rising year by year, with a trend toward affecting younger populations. Due to the dense breast tissue characteristic of Asian women, factors such as the masking effect of glandular tissue on masses and architectural distortions pose significant challenges for mammographic diagnosis. Deepwise Medical has pioneered the resolution of this challenge through its independently developed advanced AI algorithms designed for detecting ultra-small objects in high-noise environments.

Deepwise Medical has leveraged innovative deep learning technologies to drive the integration of product development and clinical research. The company has collaborated with numerous medical institutions across China to conduct a series of studies focused on breast cancer, thereby enhancing the performance of algorithms for the detection and diagnosis of breast diseases. To date, nearly 20 scientific papers have been published in top-tier conferences and SCI-indexed journals. Notably, a research achievement on the automatic detection of masses in mammography was accepted by TPAMI, a prestigious journal in the field of artificial intelligence (Impact Factor: 24.314). Currently, Deepwise Medical maintains an international leading position by integrating AI technology with cutting-edge academic advancements in breast disease, including object detection, instance segmentation, and ordinal regression.

China’s medical AI market is demonstrating a positive trajectory characterized by orderly, high-speed growth. The value of AI applications is beginning to reshape the smart healthcare ecosystem, with overall business experiencing explosive expansion as commercialization matures. The first Class III medical device certificate for breast cancer AI issued by the National Medical Products Administration (NMPA) has propelled Deepwise Healthcare to the industry forefront in terms of the number of certified AI products. Driven by robust innovation capabilities, Deepwise Healthcare achieved remarkable business growth in 2021. Building on this momentum, the company continued its significant upward trajectory in 2022, delivering professional, precise, and efficient AI products and solutions to thousands of healthcare clients across more than 30 provinces, municipalities, and autonomous regions in China, thereby comprehensively supporting the advancement of smart healthcare infrastructure.

Currently, Deepwise Healthcare has led or participated in seven key R&D programs under the Ministry of Science and Technology, 14 projects funded by the National Natural Science Foundation of China, and more than 30 provincial- and municipal-level scientific research projects. These initiatives cover multiple research areas, including medical image processing, the construction and application of knowledge systems for healthcare big data, and related digital therapeutics. Meanwhile, in the 2022 list of entities selected for the Artificial Intelligence Medical Device Innovation Tasks, publicly announced by the Ministry of Industry and Information Technology and the National Medical Products Administration, Deepwise Healthcare had six projects it led or participated in included on the list. The large number of listed projects and the broad scope of research are rare among medical artificial intelligence enterprises.

With the widespread adoption and application of new technologies, the field of medical imaging is gradually overcoming challenges and breaking through bottlenecks, empowered by technological advancements. Application scenarios are expanding beyond single-purpose diagnosis and treatment to encompass a broader range of use cases. As these scenarios continue to broaden, traditional healthcare is rapidly advancing toward the era of smart healthcare. Leveraging its diversified AI product portfolio and an unyielding spirit of innovation, Deepwise Medical will continue to develop new products, promote the translation of scientific research achievements into clinical applications, create more new scenarios and models, and usher in a new chapter in the development of medical AI.