Shukun Technology's Coronary CTA AI Receives NMPA Class III Certification, Marking Entry into Era of Precision Diagnostic Assessment
According to information from the official website of China’s National Medical Products Administration (NMPA), on February 22, Shukun Technology’s CoronaryDoc Plus, an auxiliary assessment software for vascular stenosis in coronary CT angiography images, officially received NMPA Class III medical device registration approval. This software enables automated post-processing and diagnostic analysis of coronary CT angiography (coronary CTA) images and is also applicable to the automated triage assessment of coronary arteries with >50% stenosis. As early as 2020, Shukun Technology’s coronary CTA-AI was the first globally to obtain NMPA Class III certification. The recent approval of CoronaryDoc Plus as an NMPA Class III device signifies that coronary CTA-AI has officially entered the stage of precise diagnostic assessment.
Following the approval of its Coronary CT Fractional Flow Reserve Calculation Software (Shukun-FFR) for a Class III medical device certificate by the National Medical Products Administration (NMPA) on February 10, Shukun Technology has once again secured an NMPA Class III certificate in the field of cardiovascular AI. To date, Shukun Technology is the only global healthcare AI high-tech enterprise to hold NMPA Class III certificates for both “morphological” and “functional” intelligent diagnosis and treatment of cardiovascular diseases. Leveraging its globally leading technology and continuous innovation, Shukun Technology has developed a one-stop, multimodal smart solution for heart care that provides comprehensive coverage across the entire diagnostic and therapeutic pathway for cardiovascular diseases, including screening, lesion analysis and assisted diagnosis, clinical decision support, and risk event assessment.
The "Report on Cardiovascular Health and Diseases in China 2021" indicates that the prevalence of cardiovascular diseases in China is approximately 330 million, with two out of every five deaths attributed to cardiovascular conditions, posing a severe threat to the health of the Chinese population. Coronary heart disease (CHD) is the most common form, often causing myocardial ischemia due to coronary artery stenosis. As the most routine imaging modality for CHD, coronary CT angiography (CCTA) involves complex post-processing and diagnostic workflows that are heavily reliant on the expertise of senior physicians. This has resulted in a supply-demand imbalance for CCTA examinations in cardiovascular care.
The application of coronary CTA AI can significantly enhance physicians’ work efficiency, automatically completing the entire workflow from input of patients’ raw CTA images to output of intelligent structured reports in just one minute. In addition to improved efficiency, Shukun AI’s robust learning capabilities continuously enhance its diagnostic accuracy. The largest-scale domestic multicenter validation study conducted on Shukun Technology’s coronary CTA AI demonstrated that both its sensitivity and specificity exceeded 90%.
Professor Yang Zhenghan, Director of the Department of Radiology at Beijing Friendship Hospital, Capital Medical University, stated, “Current application results indicate that for 80% of patients, the imaging diagnostic workflow for coronary heart disease can generate reports comparable to those produced by experienced radiologists without human intervention. Given the variability in judgments among different physicians, the information extracted by artificial intelligence may be more accurate and consistent than that provided by humans.”
To date, Shukun Technology’s coronary CTA AI product remains the only coronary CTA AI solution worldwide to have obtained both China NMPA Class III certification and EU MDR CE marking. In 2022, during the joint “AI Medical Device Innovation Challenge” initiated by the Ministry of Industry and Information Technology and the National Medical Products Administration, Shukun Technology was recognized as one of the ten “Leading Entities” in the intelligent assisted diagnosis category for its coronary AI project.
Hospital Application of Shukun Technology’s Coronary CTA AI for Precise Diagnostic Assessment of Stenotic Coronary Arteries
As an industry leader in cardiovascular AI, Shukun Technology’s CoronaryDoc, its coronary CTA AI product, entered the Class III medical device innovation pathway in 2019 as the only cardiovascular imaging AI solution in China. In November 2020, it officially received the world’s first medical device registration certificate for auxiliary diagnosis of coronary artery stenosis using coronary CTA. After years of continuous innovation and practical refinement through close collaboration between medicine and engineering, CoronaryDoc Plus has formally obtained its Class III certification, ushering coronary CTA-AI into a new era of precise diagnostic assessment.
Meanwhile, Shukun Technology’s Coronary CT Fractional Flow Reserve Calculation Software (Shukun-FFR) has recently received official approval for a Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA). Jointly conducted by Shukun Technology and the General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army, the largest real-world, multicenter study on CT-FFR in China demonstrated that Shukun’s CT-FFR results show good concordance with the gold standard. Without the need for additional examinations, the software can automatically output the degree of coronary artery stenosis and ischemia status upon completion of image scanning.
As the only medical AI high-tech enterprise globally to obtain dual Class III NMPA certifications for Coronary CTA and CT-FFR, Shukun Technology has developed a one-stop, fully automated Coronary CTA + CT-FFR cardiac AI suite that generates structured diagnostic reports integrating “morphology + function” within three minutes, thereby driving a transformation from morphological to functional assessment and from imaging diagnosis to clinical decision-making.
As Mao Xinsheng, Founder and Chairman of Shukun Technology, stated, “Shukun Technology has always taken it as its mission to advance industry progress through globally leading original technologies.” Building on its extensive portfolio of proprietary technologies, Shukun Technology continues to expand its “Digital Heart” product family. In addition to its one-stop, fully automated Coronary CTA + CT-FFR solution, its cardiac CT offerings include intelligent analysis of coronary artery calcium scoring, vulnerable plaque analysis, pericoronary fat attenuation index (FAI), and CT-based cardiac function. Its cardiac magnetic resonance (CMR) solutions encompass AI-powered Coronary MRA and CMR AI systems. These innovations comprehensively empower clinicians in both practice and research, delivering high-quality, multidisciplinary medical services to cardiovascular patients at all disease stages.
Professor Lü Bin, Director of the Department of Radiology at Fuwai Hospital, Chinese Academy of Medical Sciences, pointed out: “In the next 5–10 years, artificial intelligence will undoubtedly play a pivotal role in cardiovascular imaging. As the technology matures and gains wider adoption, more hospitals, including primary care institutions, will be able to leverage it for lesion analysis, allowing more patients to benefit from these technological advancements.”
Since initiating the R&D of cardiovascular AI in 2017, Shukun Technology has consecutively launched Digital Heart AI, Digital Brain AI, Digital Chest AI, and Digital Abdomen AI from 2018 to 2022, at a rate of one product per year. Currently, Shukun Technology is the only medical AI high-tech enterprise globally to have simultaneously obtained NMPA Class III certifications and MDR CE certifications in the key fields of cardiology, neurology, and thoracic medicine. The "Digital Doctor" product portfolio, represented by Digital Heart, has gradually gained recognition from the industry and medical experts. To date, Shukun Technology’s Digital Doctor products are in high-frequency daily use at nearly 3,000 medical institutions across China, including over 90% of the Top 100 hospitals and 80% of target Grade A tertiary hospitals, achieving the highest market coverage in the industry.
The Report to the 20th National Congress of the Communist Party of China explicitly emphasized “expanding high-quality medical resources and promoting their balanced regional distribution, adhering to a prevention-first approach, strengthening health management for major chronic diseases, and enhancing primary care institutions’ capabilities in disease prevention, diagnosis, treatment, and health management.” The integration of artificial intelligence (AI) with healthcare not only holds significant importance for improving the efficiency of physicians at tertiary hospitals and alleviating shortages of medical personnel, but also enhances the overall capacity of primary healthcare institutions in disease diagnosis and treatment. As such, AI represents the most powerful technological force driving the expansion of high-quality medical resources and the balanced development of healthcare services.
One of the key tasks outlined in the “Action Plan for Promoting High-Quality Development of Public Hospitals (2021–2025)” is to build “three-in-one” smart hospitals. Public hospitals with the necessary conditions are encouraged to accelerate the adoption of intelligent service software and hardware, such as AI-assisted diagnosis and treatment systems, thereby enhancing the intelligence and personalization of medical services. With the continuous application and development of Shukun AI in major disease scenarios—including cardiovascular and cerebrovascular diseases and cancer—Shukun Technology’s Digital Doctor products are providing a steady stream of intelligent support for the high-quality development of hospitals, improving patient care capabilities, and contributing to the Healthy China Initiative.