Ruixin Medical Receives NMPA Class III Innovation Approval for Ruixin-FFR, Enabling More Precise and Rational Stent Placement

Recently, the coronary CT-derived fractional flow reserve calculation software developed by Shenzhen Raysightmed Co., Ltd.—Raysight FFR (Ruixin-FFR)—has received NMPA Class III medical device approval. RaysightMed completed the entire process for this Class III medical product, including R&D and testing, large-scale prospective clinical study validation, and regulatory submission and approval, in just three years.

In 2020, the inclusion of high-value consumables such as coronary stents in centralized procurement caused a significant stir within the industry. However, beyond the initial uproar, a more critical issue urgently needs to be addressed: How can stents be utilized to achieve better therapeutic outcomes? Despite the high prevalence of coronary heart disease (CHD), its diagnosis has long presented challenges. Multiple large-scale international studies have demonstrated that the currently common diagnostic technique in China—invasive coronary angiography—does not yield better prognostic outcomes for stent-guided therapy compared to medical management alone. The fundamental reason is that coronary angiography only reveals morphological stenosis information and cannot assess whether the vessel’s actual blood supply function is compromised.

RaysightMed’s RayScore, launched over a three-year period, leverages artificial intelligence and scientific computing technologies to assess the blood supply function of diseased vessels, thereby providing a robust basis for the precise diagnosis and treatment of cardiovascular diseases.

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Building a precision assessment platform for cardiovascular and cerebrovascular diseases on the foundation of artificial intelligence and scientific computing technologies signifies years of deep cultivation and exploration in technological and engineering accumulation. In the industrial sector, China’s field of engineering simulation lags behind the West by several decades, while the human body represents an even more complex system with higher barriers to entry for professional technical frameworks. The three founders of RaysightMed (Zheng Lingxiao, Lan Hongzhi, and Ma Jun) possess over a decade of R&D experience in this field in the United States, enabling the product to stand on the shoulders of giants from its inception.

RuiXin Score is characterized by its precision, efficiency, and non-invasive safety. With an accuracy of 92%, specificity of 90%, and sensitivity of 95%, it stands out in the industry. It maintains globally leading accuracy even in special cases such as gray-zone lesions, calcified lesions, and diffuse lesions. It enables plaque risk assessment and supports preoperative planning for interventions including stent placement, balloon angioplasty, and coronary artery bypass grafting (CABG), becoming the industry’s first coronary perfusion function assessment platform integrating “morphology” and “functionality.”

Behind this perfect achievement lies the support of over 100 academic papers, software copyrights, and patents; it embodies the expertise of a team of professionals specializing in AI deep learning, cloud computing, and biological simulation; it has undergone rigorous validation through the world’s largest prospective clinical trial, involving 330 cases across six authoritative centers; and it has been extensively applied in more than 30,000 clinical cases after deployment in over 200 Grade A tertiary hospitals. The substantial early-stage investments have incrementally established the competitive moat for Raysight Fractional Flow Reserve (Raysight-FFR), securing RaysightMed’s position at the forefront of the intelligent healthcare sector.

No enterprise can achieve success without the support of commercialization. In 2019, Liu Xiaoyang, then National Sales Director at Sanofi, joined the founding team of RaysightMed, forming the “F4 Super Engine” alongside the original “Three Musketeers”—Zheng Lingxiao, Lan Hongzhi, and Ma Jun. The integration of a technically proficient team, educated in the United States, with top-tier industry sales experts enabled RaysightMed to establish a clear strategic positioning: to become a world-leading flagship enterprise in intelligent healthcare, developing a series of innovative technologies and products that spearhead emerging trends in future medical care.

Upon learning that RaysightMed’s FFRct has qualified for listing, Professor Liu Jian from Peking University People’s Hospital extended his congratulations, stating, “The outstanding performance of RaysightMed’s FFRct clearly demonstrates the immense potential for RaysightMed’s future development.”

Zheng Lingxiao, CEO of RaysightMed, stated that the launch of the RayScore marks the first step in RaysightMed’s overall strategic layout, with all pain points in intelligent diagnosis and treatment serving as key drivers for development. Moving forward, RaysightMed will go full steam ahead, focusing on the entire digital healthcare ecosystem to swiftly implement its long-prepared, comprehensive empowerment of diagnosis and treatment across cardiovascular, cerebrovascular, and peripheral vascular conditions. RaysightMed will explore more products and provide enhanced services to bring greater value to physicians and patients, ultimately realizing its mission: “to ensure every blood vessel receives the earliest diagnosis and the most precise treatment.”