Shukun Technology's CT-FFR Product Receives NMPA Class III Certification, Establishing Global Benchmark in AI-Powered Cardiovascular Diagnosis

According to the official website of China’s National Medical Products Administration (NMPA), on February 3, Shukun Technology’s Coronary CT Fractional Flow Reserve Calculation Software (Shukun-FFR) officially received NMPA Class III medical device registration approval. The software can automatically assess the fractional flow reserve at any location within coronary arteries, marking another major breakthrough in clinical access for digital human technology-assisted diagnostic support, following its earlier advancements in coronary AI, stroke AI, thoracic tumor AI, and pneumonia AI.

Following the approval of its coronary AI for NMPA Class III certification in 2020, Shukun Technology has become the only medical AI high-tech enterprise globally to hold simultaneous NMPA Class III certifications for both “morphological” and “functional” intelligent diagnosis and treatment of cardiovascular diseases, setting a global benchmark for one-stop AI-driven diagnosis and treatment of cardiovascular conditions.

The "Report on Cardiovascular Health and Diseases in China 2021" shows that the number of prevalent cases of cardiovascular diseases in China is approximately 330 million, including 11.39 million patients with coronary heart disease. Among all deaths due to illness, the mortality rates from cardiovascular diseases among rural and urban residents account for 46.74% and 44.26%, respectively, meaning that 2 out of every 5 deaths are caused by cardiovascular diseases. Cardiovascular diseases pose a serious threat to human health and represent a key challenge being addressed in the medical field.

Fractional Flow Reserve (FFR) is the gold standard for assessing the physiological function of coronary arteries, but its clinical application is limited by factors such as invasiveness, high cost, and susceptibility to complications. In recent years, CT-derived Fractional Flow Reserve (CT-FFR), obtained by applying AI technology to Coronary Computed Tomography Angiography (CCTA) data, has emerged as a new focus in clinical practice and research. It enables fully automated assessment of both coronary morphology and function through a single non-invasive examination.

As one of the earliest hospitals in China to conduct CT-FFR research, the General Hospital of Eastern Theater Command of the Chinese People's Liberation Army ranks fifth nationwide in radiology and enjoys a long-standing reputation both domestically and internationally for its diagnosis and treatment of cardiovascular and cerebrovascular diseases. In June 2021, Shukun Technology and the General Hospital of Eastern Theater Command of the Chinese People's Liberation Army jointly established the largest real-world multicenter CT-FFR study in China, with collaboration from over 30 institutions to validate its clinical effectiveness.

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Professor Zhang Longjiang, Director of the Department of Radiological Diagnosis at Jinling Hospital (Eastern Theater Command General Hospital), pointed out in an industry sharing session: “There is an urgent clinical need for more precise non-invasive assessment tools for coronary artery stenosis. As an innovative solution, CT-derived fractional flow reserve has had its diagnostic performance validated by clinical evidence and recognized by expert consensus.”

Clinical study results demonstrate that Shukun Technology’s CT-FFR exhibits strong concordance with the gold standard, offering a novel option for the diagnosis and treatment of coronary artery disease (CAD). Patients require no additional testing, and physicians can obtain precise, fully automated assessments of coronary stenosis severity and myocardial ischemia immediately after image acquisition, without manual intervention. By leveraging AI-assisted diagnostics to deliver more accurate results, Shukun Technology’s CT-FFR reduces reliance on individual clinical experience in assessing the impact of coronary stenosis on myocardial ischemia, thereby becoming an indispensable intelligent assistant for physicians.

As an industry leader in cardiovascular AI, Shukun Technology’s CoronaryDoc, its coronary CTA AI product, entered the Class III innovative device review pathway in 2019 as the only cardiovascular imaging AI solution in China. It officially received the NMPA Class III medical device registration certificate in November 2020. CoronaryDoc has undergone the largest-scale multicenter validation for coronary arteries in China, reducing post-processing and diagnostic time by 80%, with both sensitivity and specificity exceeding 90%. Shukun Technology’s one-stop, fully automated coronary CTA + CT-FFR cardiac AI suite can generate a structured diagnostic report covering both “morphology and function” within three minutes, driving a transformation from morphological to functional assessment, and from imaging diagnosis to clinical decision-making.

To date, Shukun Technology’s CoronaryDoc remains the only coronary CTA AI product worldwide to have obtained both China NMPA Class III certification and EU MDR CE marking. In 2022, during the joint “Open Competition” initiative for innovative AI medical devices launched by the Ministry of Industry and Information Technology and the National Medical Products Administration, Shukun Technology was named one of the ten “Leading Entities” in the intelligent assisted diagnosis category for its coronary AI project.

Shukun Technology has continuously expanded its “Digital Heart” product portfolio, leveraging multiple proprietary technologies. In addition to the one-stop fully automated coronary CTA + CT-FFR solution, its cardiac CT offerings include intelligent analysis of coronary artery calcium scoring, vulnerable coronary plaques, pericoronary adipose tissue, and CT-based cardiac function. Its cardiac MRI solutions encompass AI systems for coronary MRA and CMR. These tools comprehensively empower clinicians in both clinical practice and research, providing high-quality, multidisciplinary medical support for cardiovascular disease patients at various stages. Adhering to a platform-oriented R&D strategy, Shukun Technology has developed a one-stop, multimodal smart solution for cardiac diagnosis and treatment that covers the entire care pathway—from disease screening and AI-assisted lesion analysis and diagnosis to AI-supported clinical decision-making.

At an industry conference, Professor Lü Bin, Director of the Department of Radiology at Fuwai Hospital, Chinese Academy of Medical Sciences, pointed out that artificial intelligence will undoubtedly play a crucial role in cardiovascular imaging over the next 5 to 10 years. As the technology matures and becomes more widely adopted, more hospitals, including primary care institutions, will be able to leverage AI for lesion analysis, enabling a broader patient population to benefit from these technological advancements.

Medical AI has entered the stage of large-scale industrial implementation, not only significantly reducing doctors’ workload and improving work efficiency but also aligning with the direction of high-quality development in public hospitals. Shukun Technology’s “Digital Heart” product family has been widely welcomed by healthcare institutions since its launch.

With the implementation of policies such as the “Healthy China 2030” Planning Outline and the Action Plan for Promoting High-Quality Development of Public Hospitals (2021–2025), the intelligence and personalization of medical services are accelerating. To date, Shukun Technology’s Digital Doctor products have been deployed in nearly 3,000 medical institutions across China, ranking first in the industry for market coverage; its coronary artery calcium scoring product has served hundreds of health examination centers nationwide in preventive care settings, facilitating earlier and more precise disease screening and diagnosis, and benefiting hundreds of millions of patients with cardiovascular diseases.

2023 is a pivotal year for comprehensively building a modern socialist country. Shukun Technology will continue to leverage its proprietary technologies to drive the modernization and upgrading of industries, fully empower the digital transformation of the healthcare sector, further benefit patients and medical professionals alike, and contribute to realizing the visionary goal of “Healthy China.”

Shukun Technology is a world-leading intelligent healthcare technology platform, committed to providing smart products and innovative solutions for the healthcare industry with China-originated, globally leading technologies. Shukun Technology is dedicated to building the "Digital Human," a globally leading healthcare brain. Targeting major common and chronic diseases such as cardiovascular and cerebrovascular diseases and tumors, it has independently developed a portfolio of "Digital Doctor" products covering the entire process of disease screening, assisted diagnosis, and treatment decision-making. These products have been successfully applied in three key areas: intelligent imaging, intelligent surgery, and intelligent health management.

To date, Shukun Technology is the world’s only medical AI high-tech enterprise to simultaneously hold NMPA Class III approvals and MDR CE certifications in the three key areas of cardiology, neurology, and thoracic imaging. It was also the first to secure NMPA Class III approval, EU MDR CE certification, and U.S. FDA clearance in the field of cerebrovascular diseases. Shukun Technology’s “Digital Doctor” products are in high-frequency daily use at nearly 3,000 healthcare institutions across China, including over 90% of the top 100 hospitals and 80% of targeted public Grade A tertiary hospitals, ranking first in the industry for market coverage.

At a time when the healthcare industry is making significant strides toward digitalization and intelligence, Shukun Technology is deeply integrating medical practice with engineering through collaborations with top-tier hospitals, industry experts, and research institutions. By continuously expanding the broad application of advanced technologies such as artificial intelligence in healthcare, Shukun Technology supports the high-quality development of the global healthcare industry, enabling people to access ubiquitous smart healthcare services.