RuiXin-FFR Secures First Domestic CE Certification under EU MDR for CT-FFR Technology, Marking Global Expansion Milestone

Recently, the non-invasive coronary artery blood flow reserve fraction assessment software independently developed by Shenzhen Raysightmed Co, Ltd. (hereinafter referred to as "RaysightMed") ——RuiXin-FFR Officially Receives EU CE Certification Approval.

It is reported that the EU CE certification was reformed in 2017, upgrading from the MDD (Medical Device Directive) review mechanism to the MDR (Medical Device Regulation). Compared with MDD, the MDR regulation has a stricter pre-market review threshold, enhances product transparency and traceability, strengthens vigilance and market supervision, and reinforces the responsibilities of manufacturers, NBs, and European representatives.

Compared with the MDD directive, it is more difficult to obtain certification under the MDR regulations, and the audit and issuance cycles are longer.Therefore, products certified under the MDR have higher safety and efficacy, providing an additional layer of assurance for clinical applications and patient health. Moreover, MDD certificates issued during the MDR transitional period will expire after 2027 and cannot be used in the EU market.RuiXin-FFR is the first CT-FFR product approved in China after the EU CE certification regulations were tightened.

Taking this as an opportunity, RaysightMed will further promote the accessibility of its solutions to more countries. This also marks that RaysightMed has the capability to go international and, as a China-based manufacturer, has successfully taken an important step in expanding into key global regions, with a promising future ahead. The recent acquisition of the first EU CE certification in the CT-FFR field under the MDR regulation by RuiXin-FFR holds significant importance for both domestic and international markets, as well as for RaysightMed.

As the world's first non-invasive coronary blood supply function assessment platform that integrates "morphology" and "function",RuiXin-FFR is currently the CT-FFR product with the highest assessment accuracy globally.Validated by the largest-scale (330 cases) prospective clinical trial in the same field globally,The product has an accuracy rate of up to 92%, with a sensitivity of 95% and a specificity of 90%.For special cases such as gray zones, calcification, and diffuse lesions, the product maintains high accuracy. With its clinical value in non-invasive procedures, providing coronary artery assessment reports within 5 minutes, triaging patients who truly require invasive treatment during the outpatient stage, and precisely formulating the next steps for diagnosis and treatment, RuiXin-FFR demonstrates significant health economic implications.Continuously promote the transformation and upgrading of traditional medical paradigms toward the goals of "minimizing iatrogenic harm" and "maximizing health benefits."

It is reported that RuiXin-FFR was officially released in November 2018; in March 2020, it entered the NMPA's innovative medical device green channel; in June 2020, it completed the world's largest prospective clinical trial in the same field; in April 2021, after being certified by the National Medical Products Administration (NMPA) as an innovative Class III medical device, RuiXin-FFR has been included in the billing directories of more than ten provinces and cities in China. It has cooperated with over 800 tertiary hospitals, with clinical application cases exceeding 110,000+. Meanwhile, it has diversified its cooperation to multiple imaging testing institutions and insurance companies, and has been integrated into several smart healthcare solution platforms such as Philips' Shénfēi Cloud, providing precise and non-invasive cardiovascular function evaluation services for more patients.

At the same time, in clinical and academic aspects, RuiXin-FFR (RaysightMed's FFR) continues to achieve new breakthroughs:

In May 2021, RaysightMed, in collaboration with Zhongshan Hospital Affiliated to Fudan University, launched a national-level "Health Economics" research project on Coronary CT-derived Fractional Flow Reserve (CT-FFR) in China.

On July 13, 2022, the Beijing Municipal Medical Insurance Bureau issued the "Notice on Printing and Distributing the Management Measures for Exclusion of New Drugs and New Technologies from CHS-DRG Payment (Trial)" which proposed the DRG exclusion payment method. It clearly stated that innovative drugs, innovative medical devices, and innovative medical service projects can be paid separately based on actual costs, rather than through the DRG payment method. "RuiXin-FFR," independently developed by RaysightMed, is among those included.

In April 2023, to further enhance clinical practitioners' understanding of CT-FFR and promote its clinical adoption and rational standardized application, the Echocardiography and Imaging Group of the Cardiovascular Physicians Branch of the Chinese Medical Doctor Association and the Editorial Board of the Chinese Journal of Interventional Cardiology jointly organized relevant experts to release the first domestic "Chinese Expert Consensus on the Clinical Pathway for Coronary CT Blood Flow Reserve Application," marking a milestone significance for the clinical application of CT-FFR.

On May 27, 2023, during the "17th Oriental Conference of Cardiology," the "CONFIDENT Clinical Trial," supported by RaysightMed, was officially launched. This study holds milestone significance for further exploring CT-FFR-guided clinical diagnosis and treatment processes tailored to China's specific national conditions, and for establishing a more efficient, streamlined, and interconnected clinical diagnostic and treatment system.

This time, the CE certification obtained by RuiXin-FFR demonstrates the progress of Chinese artificial intelligence enterprises. Addressing the key challenges in the diagnosis and treatment of cardiovascular and cerebrovascular diseases, RaysightMed has also launched products such as "RuiXin-CoronaryAI," "RuiXin Angiography FFR Auxiliary Diagnosis System," "RuiXin Surgical Planning Simulation System," and "RuiXin Cardiovascular Interventional Surgical Robot," forming a product system that covers disease screening, diagnosis, treatment, and prognosis management.

These products can not only meet the needs of the domestic market in China but also comply with the standards of overseas markets. RaysightMed will take this opportunity,Further expand overseas markets to bring more advanced technologies and products to more countries.

The approval of this EU CE certification means that under the higher standards of the MDR new regulations, the international market affirms RaysightMed's technological innovation capabilities, product quality, and clinical outcomes.

Now, RaysightMed is leveraging its team's technical and engineering expertise, along with years of deep cultivation and continuous efforts in market expansion. While firmly rooted in China and addressing the pain points of domestic cardiovascular diagnosis and treatment, the company is further advancing into overseas markets based on solid clinical research, embarking on a path to global scalability.