Shukun's Coronary and Pneumonia AI Products Receive EU MDR CE Certification, Advancing Global Access to Intelligent Healthcare

On May 27, Shukun’s AI-assisted diagnostic products for coronary arteries and pneumonia both obtained EU MDR CE certificates. Shukun’s coronary AI product is the first coronary AI to receive EU CE certification and the only coronary AI in China to hold both NMPA and CE certifications.

CE marking is a prerequisite for medical device products to enter most countries centered in Europe, while the Medical Device Regulation (MDR) is a new regulation issued by the European Commission in response to the development of the medical device industry, imposing stricter requirements on pre-market clinical evaluation and testing.

On May 5, 2017, the European Union officially released the new Medical Device Regulation (MDR) (EU 2017/745), replacing the old Medical Devices Directive (MDD) (93/42/EEC). The transition period between the old and new regulations was three years. On April 24, 2020, the EU officially announced a one-year postponement of the mandatory implementation date of the Medical Device Regulation (MDR), rescheduling it to take effect on May 26, 2021.

Under the new Medical Device Regulation (MDR), medical devices entering the European market will be subject to stricter restrictions, while the increased difficulty of the application process imposes higher requirements on industry practitioners. Shukun’s two AI products have obtained EU CE certification, which means that Shukun’s AI products will be able to enter the EU market shortly.

Cardiovascular disease is the leading cause of morbidity and mortality worldwide. Myocardial ischemia caused by coronary artery stenosis, commonly known as coronary heart disease (CHD), is the most prevalent form of cardiovascular disease. In China, approximately one-fifth of the population suffers from cardiovascular disease, meaning that nearly every family may have a member affected by this condition.

It is reported that Shukun Technology’s coronary AI product meets the requirements for superior efficacy. Its artificial intelligence system automates processes such as 3D reconstruction, interpretation, assessment, and report review of coronary CTA, reducing the manual post-processing time by radiologists from 30–40 minutes to just a few minutes without human intervention, thereby alleviating the workload of imaging physicians.

Pneumonia is one of the most common diseases worldwide, with numerous subtypes, the vast majority of which present with ill-defined margins. By leveraging artificial intelligence-based whole-lung quantitative analysis technology, we provide clinical experts with intelligent, CT imaging-derived quantitative lesion analysis and treatment efficacy evaluation, thereby offering evidence-based support for clinical decision-making and enabling rapid assisted diagnosis.

Europe currently has a population of 500 million, with a substantial number of patients suffering from cardiovascular and pulmonary diseases. Shukun Technology’s AI products have obtained EU MDR CE certification. Building on its successful service to hundreds of millions of patients in China with cardiovascular and pneumonia-related conditions, the company will continue to serve patients with related diseases in the European Union, extending the benefits of intelligent healthcare services to medical professionals and patients worldwide.