Infervision Secures NMPA Class III Certification for Coronary AI, Becoming the Only Chinese AI Company with Class III Approvals in Thoracic, Cerebral, and Cardiac Domains

According to information from the official website of the National Medical Products Administration (NMPA), Infervision’s software for auxiliary assessment of vascular stenosis in coronary CT angiography images has recently been officially granted a Class III medical device registration certificate by the NMPA, for use in auxiliary triage and evaluation of coronary CTA. Furthermore, this approval carries no post-market conditions, indicating that the product possesses superior generalization capabilities and is compatible with equipment from various manufacturers across hospitals at all levels. With this achievement, Infervision has become an AI healthcare technology company holding NMPA Class III certifications simultaneously in the three key diagnostic and therapeutic domains of thorax, brain, and heart.

The "Report on Cardiovascular Health and Diseases in China 2021," released by the National Center for Cardiovascular Diseases, indicates that with socioeconomic development and changes in national lifestyles, the impact of cardiovascular risk factors on residents' health has become increasingly significant, and the incidence of cardiovascular diseases continues to rise. Currently, cardiovascular disease is the leading cause of death among both urban and rural residents in China. The economic burden imposed by cardiovascular disease on individuals and society is growing progressively heavier, making it a major public health issue¹. Coronary heart disease (CHD), fully known as coronary atherosclerotic heart disease, is the most common cardiovascular disease and the cardiac condition with the highest case fatality rate.

Currently, AI-assisted imaging evaluation has become a critical clinical need in the diagnosis and treatment of coronary artery disease. Infervision’s software for assisted assessment of vascular stenosis in coronary CT angiography images is designed for the display, processing, and analysis of coronary CT angiography (CCTA) images. It provides triage support by assessing whether coronary arteries exhibit stenosis of 50% or greater.

The Infervision product “AI-Assisted Assessment Software for Vascular Stenosis in Coronary CT Angiography Images,” recently approved, underwent a multicenter, retrospective clinical trial led by Jiangsu Province Hospital. The trial results demonstrated that the software exhibits excellent performance in the assisted assessment of obstructive coronary stenosis, provides more precise AI-based imaging assistance, significantly reduces reconstruction and image interpretation time, and delivers substantial clinical value.

As early as 2018, Infervision published a paper in JACC: Cardiovascular Imaging, a top-tier subspecialty journal in the field of international cardiovascular medicine (Impact Factor: 14), demonstrating that Infervision’s AI is more accurate than traditional models in predicting coronary artery stenosis. This represents one of the few highly valuable and cutting-edge studies in China’s cardiovascular AI sector. Driven by innovation in clinical practice, Infervision has achieved multiple scientific breakthroughs in deep learning-based auxiliary assessment of coronary arteries. These achievements fully attest to the advanced nature and clinical usability of Infervision’s deep learning algorithms for identifying coronary lesions.

To further empower clinical practice and scientific research, Infervision has been continuously expanding its solutions in the field of cardiovascular imaging AI, facilitating the early realization of precise diagnosis and treatment for cardiovascular diseases. In the realm of coronary artery research, it enables automated measurement of calcium scoring, automatic identification and segmentation of the heart and blood vessels, automatic reconstruction of multi-sequence images, intelligent computer-aided diagnosis aligned with clinical guidelines, quantitative analysis of plaque composition, intelligent calculation of coronary CT-derived fractional flow reserve (CT-FFR), automated quantification of pericoronary adipose tissue, and automatic generation of transluminal attenuation gradient (TAG) curves, thereby covering the entire diagnostic pathway from coronary morphology to function.

As of July 2023, Infervision is the first and only Chinese AI healthcare technology company to have its products receive regulatory approval in five major markets: China, the United States, the European Union, the United Kingdom, and Japan. Having secured market access in most of the world’s major healthcare markets, Infervision’s products are now deployed in more than 1,000 medical institutions across over 20 countries worldwide. With this recent approval of its coronary AI solution, Infervision has become an AI-driven high-tech medical company holding Class III certifications from the National Medical Products Administration (NMPA) in three key diagnostic and therapeutic areas: thoracic, neurological, and cardiovascular care.

In the field of AI-assisted thoracic diagnosis, Infervision has obtained three Class III medical device registrations from the National Medical Products Administration (NMPA), securing comprehensive Class III NMPA certifications for pulmonary nodules, pneumonia, and thoracic fractures. This achievement establishes the “golden quartet” of thoracic AI solutions, enabling efficient multi-disease screening for various chest conditions in China.

In the field of AI-assisted triage for neurological conditions, Infervision’s stroke AI product has become the first in China to achieve dual certification from both the NMPA and the FDA, earning consistent recognition from regulatory authorities domestically and internationally. Furthermore, Infervision’s stroke project has been selected for the MIIT and National Health Commission’s 5G + Healthcare Application Pilot Program.

The “Action Plan for Promoting High-Quality Development of Public Hospitals (2021–2025)” explicitly states that “public hospitals with the necessary conditions are encouraged to accelerate the adoption of smart service software and hardware, such as AI-assisted diagnosis and treatment systems, so as to enhance the intelligence and personalization of medical services, promote the standardization and normalization of hospital informatization construction, and implement national and industry-specific informatization standards.” The high-quality development of public hospitals requires concerted efforts across the entire industry. As Infervision continues to expand its comprehensive product portfolio along both horizontal and vertical dimensions, it will provide an increasing number of innovative, high-quality solutions to support the high-quality development of public hospitals, thereby helping improve the quality and efficiency of the healthcare delivery system, genuinely enhancing patients’ medical experience, and enabling the public to benefit from more precise and higher-quality medical services.

References:

[1] Official WeChat Account of the National Center for Cardiovascular Diseases, https://mp.weixin.qq.com/s/7116YOYpwwf34mDiElYIzg

[2] Official Website of the Central People's Government of the People's Republic of China, www.gov.cn