Deepwise Medical Secures Two NMPA Class III Certifications in One Week for Innovative Intracranial Aneurysm AI Software and Smart Bone Age X-ray System

DeepWise’s AI-Assisted Detection Software for Intracranial Aneurysms in CT Angiography Images Has Received NMPA Class III Certification via the Innovative Medical Device Pathway. This marks DeepWise’s second AI-based medical imaging product approved as an innovative medical device, and it is the first innovative artificial intelligence system for intracranial aneurysm detection in CT scans in China. Previously, DeepWise’s pulmonary nodule AI system was among the first 100 innovative medical devices approved in China. Currently, DeepWise is one of the companies with the largest portfolio of innovative medical devices in the medical AI industry.Just a few days ago, the AI-powered X-ray Bone Age Assessment System, independently developed by Canglan Medical, a subsidiary of DeepWise, also received Class III certification. This is the first highly integrated smart equipment in China combining software and hardware with advanced artificial intelligence technologies. The approval of these two Class III certificates not only solidifies DeepWise’s leading position in terms of the number of certifications held within the industry but also signifies its expansion from AI-based imaging systems into AI-powered smart equipment. With robust product R&D and innovation capabilities, DeepWise has become the only high-tech enterprise in China’s medical AI sector that possesses both AI intelligent equipment and AI imaging products.

Intracranial aneurysms are associated with extremely high rates of mortality and disability. Upon rupture and hemorrhage, 10%–15% of patients may suffer sudden death before receiving medical attention. The case fatality rate for the initial hemorrhage is 35%, while that for rebleeding can reach as high as 60%–80%. Therefore, prevention, treatment, and early detection of intracranial aneurysms are critically important. In recent years, CT angiography (CTA) has become one of the primary diagnostic methods for intracranial aneurysms due to its cost-effectiveness and convenience. CTA is considered the preferred imaging modality for patients with acute aneurysmal subarachnoid hemorrhage.

DeepWise has obtained certification for the first innovative AI-based imaging detection product for intracranial aneurysms in China to receive a Class III medical device certificate from the National Medical Products Administration (NMPA). In addition to basic triage functionality, this product is designed for the display, processing, measurement, and analysis of computed tomography angiography (CTA) images of the head and neck arteries. It provides assisted detection of intracranial aneurysms, offering more comprehensive and detailed detection parameters to deliver professional auxiliary assessments that support physicians in making precise diagnoses.

The Innovative Medical Device Approval Channel, established by the National Medical Products Administration (NMPA) of China in 2014, has received over 2,000 applications for innovative products, with fewer than 30% ultimately approved and publicly listed. To obtain an NMPA Class III certification for an innovative medical device, a product must first meet stringent criteria, including: having a core working principle or mechanism of action that is a domestic first; achieving international leadership in technology; demonstrating significant clinical value; ensuring a authentic and controllable research process with complete and traceable data; and having a basically finalized product. These requirements pose a substantial test to a company’s R&D capabilities and innovative strength. To date, DeepWise holds two NMPA Class III certifications for innovative medical devices. Its AI-based pulmonary nodule product was the 98th approved, and its intracranial aneurysm product was the 253rd, both ranking among the forefront of approved innovative products.

The intracranial aneurysm AI product recently certified for DeepWise is also a key component of the Ruiying Auxiliary Diagnosis System within DeepWise’s Deepwise MetAI intelligent imaging and big data general platform. By integrating multiple systems from the Ruiying series—including ASPECTS scoring, head and neck CTA, cerebral perfusion (CTP), and intracerebral hemorrhage detection—DeepWise provides a comprehensive, one-stop artificial intelligence stroke platform service targeting the two major clinical scenarios of ischemic and hemorrhagic stroke. This product has also been developed through deep industry-academia-research collaborations with numerous medical institutions in China, with its technological and clinical application achievements already《Nature Communications》Published (Impact Factor: 16.6), this represents a rare global multicenter validation of AI-based intracranial aneurysm detection. Furthermore, driven by robust technological innovation and extensive application scenarios, the product has previously garnered numerous industry accolades, including recognition as a demonstration case in the Beijing National Artificial Intelligence Innovation Application Pilot Zone.

Bone age reflects an individual's level of growth and development as well as their degree of maturity, and it has extensive applications in clinical medicine, forensic science, and sports medicine.

DeepWise’s subsidiary, Canglan Medical, has independently developed an AI-powered X-ray bone age assessment system that highly integrates the hardware’s imaging mode with the intelligent software’s evaluation mode, providing a one-stop, device-based intelligent solution for monitoring children’s growth and development. The deep integration of artificial intelligence into both image acquisition and bone age assessment imposes higher demands on corporate R&D capabilities. Leveraging its extensive expertise in the field of artificial intelligence, DeepWise has revolutionized the industry by merging two previously independent workflows into one. Whether in terms of image acquisition or bone age evaluation, this AI-powered X-ray bone age assessment system demonstrates unique advantages. Compared to most bone age examination devices currently available on the market, the Canglan AI-powered X-ray bone age assessment system is the first and, to date, the only smart medical device in China to hold a Class III certification from the National Medical Products Administration (NMPA). Equipped with a high-definition X-ray tube, self-shielding technology, and wireless remote control capabilities, the device ensures high-quality imaging while minimizing radiation exposure. It also automatically completes bone age assessments and generates growth and development evaluation reports with a single click. This certification marks a milestone, indicating that the highly integrated, all-in-one intelligent workflow of combined hardware and software will disrupt traditional bone age assessment processes, leaving behind outdated methods and ushering in a new era of intelligent bone age evaluation.

Currently, the Canglan AI X-ray Bone Age Instrument, featuring an innovative all-in-one hardware and software integration model with highly intelligent equipment, provides smarter, more convenient, and safer bone age assessments for numerous medical institutions across China. Meanwhile, leveraging intelligent medical big data governance technologies, DeepWise has collaborated with local governments to implement its Intelligent Health Management Platform for Children’s Growth and Development in regions such as Xinjiang, Shanghai, Jiangsu, and Zhejiang. These initiatives have significantly enhanced the efficiency and quality of screening for abnormal growth and development in children, as well as their overall health management. By harnessing innovative AI technologies, the platform delivers comprehensive decision support for clinical diagnosis and treatment, clinical research, patient services, and regional collaboration. This drives advancements in disciplinary capabilities and elevates the standards of medical care, education, research, and management for specific diseases at the regional level, thereby fully empowering the field of children’s health across regions.

Two Certifications in One Week: This is the speed of DeepWise, and also the pace at which artificial intelligence is advancing in the healthcare sector. Rapid technological advancements are providing greater possibilities for promoting disease research and enhancing clinical diagnostic capabilities. DeepWise will remain committed to the smart healthcare industry, leveraging its dual AI engines for “imaging + text.” Upholding technological, scientific, and business model innovation as its core, DeepWise will strengthen deep industry-academia-research collaborations with medical institutions at all levels. From smart imaging and medical big data to intelligent equipment, DeepWise continues to expand application boundaries through a diversified AI product matrix, creating new scenarios and models, and ushering in a new chapter in the development of medical AI.