UNION STRONG's Globally First-in-Class AI-Powered Decision Support Software for Intracranial Aneurysm Risk Assessment Enters NMPA Innovation Review Green Channel

Union Strong: The World’s First Groundbreaking “AI + Decision-Making” Product^®"UKnow," jointly developed by Professor Yang Xinjian's team at Beijing Tiantan Hospital, Capital Medical University, and Professor Zhang Hongqi's team at Xuanwu Hospital, Capital Medical University^®“Risk” Intracranial Aneurysm Auxiliary Assessment Software, which for the first time applies AI technology to key decision-making processes in disease treatment. After years of accumulation, exploration, and research and development, this product fully entered the clinical trial phase for registration in 2022 and was officially approved to enter the National Medical Products Administration’s Special Review Procedure for Innovative Medical Devices on April 24, 2023!

This is the first AI decision-making software in China to enter the National Medical Products Administration’s (NMPA) Green Channel for Innovative Approval. As a commercialized outcome of scientific research from the 2016 National Key R&D Program of the Ministry of Science and Technology, “Standardized Early Treatment of Ruptured Intracranial Aneurysm Hemorrhage and Study on Hemorrhage Risk of Unruptured Aneurysms,” and the 2021 National Natural Science Foundation General Program, “AI Analysis and Mechanism Study of Instability Risk Factors for Intracranial Aneurysms Based on Prospective Cohorts,” this product is not only an original Chinese innovation with multiple domestic and international invention patents granted, but also a global first that fills an international gap. In 2022, it was included in the list of selected candidates for the AI Medical Device Innovation Task Force, jointly organized by the Ministry of Industry and Information Technology and the NMPA. This software is developed by Union Strong^®Following China’s first Class III innovative medical device certificate for AI+ therapy, “UKnow^®the second disruptive innovative product following the “Intracranial Aneurysm Surgical Planning Software,” which has consecutively been approved for entry into the National Medical Products Administration’s Green Channel for Innovative Approval as a “global first,” not only demonstrates Union Strong^®Its unwavering commitment to reshaping key aspects of cerebrovascular disease diagnosis and treatment with AI further underscores its persistent efforts to lead global medical technology innovation through original Chinese innovations.

《UKnow^®“UKnow Risk” Intracranial Aneurysm Auxiliary Assessment Software is a decision-support software developed using artificial intelligence technology, trained on multi-center, large-sample, multimodal composite follow-up data from the Chinese population. It is designed to assess the stability of unruptured intracranial aneurysms, thereby assisting physicians in formulating treatment strategies. Stable aneurysms may be managed conservatively with follow-up observation, while unstable ones require immediate surgical intervention. Unlike traditional treatment decision-making that relies solely on physicians’ clinical experience, “UKnow^®“Risk” Intracranial Aneurysm Adjunctive Assessment Software comprehensively analyzes patients’ multidimensional high-risk factors, including demographics, medical history, family history, smoking and alcohol use, symptoms, laboratory tests, and aneurysm imaging data, to provide a one-stop AI-based assessment. With the software’s assistance, physicians can conduct personalized and precise evaluations for treatment decision-making regarding unruptured intracranial aneurysms, offering standardized solutions to complex clinical problems influenced by multiple factors. This addresses key pain points for both physicians and patients in making critical decisions on selecting the optimal treatment modality and timing of intervention.

The prevalence of unruptured intracranial aneurysms among adults in China is as high as 7%, which is 2–4 times that of adult populations in Europe and the United States. Moreover, with advances in imaging technology and the widespread adoption of health screening programs, an increasing number of patients are being diagnosed. Multiple domestic and international studies have shown that the annual rupture rate of unruptured intracranial aneurysms is approximately 0.95%–2%. Rupture leads to acute intracerebral hemorrhage, with a mortality and disability rate as high as 60%, resulting in a very poor prognosis.

It is worth noting that intracranial aneurysms are “ticking time bombs” in the brain, with unpredictable timing of rupture. Aneurysms assessed as unstable have effectively entered a countdown to rupture and require timely surgical intervention to prevent ruptured hemorrhage and save the patient’s life. In contrast, aneurysms assessed as stable can be managed with follow-up observation and conservative treatment, thereby sparing patients the burdens of surgery while avoiding the 3–10% risk of postoperative complications and the 1–5% risk of mortality associated with the procedure itself. Therefore, analyzing risk factors for unruptured intracranial aneurysms and conducting scientifically precise AI-based decision-making assessments to weigh the risks and benefits of surgery against the natural risk of aneurysm rupture is critically important.

However, numerous risk factors influence aneurysm stability. These are associated not only with congenital genetic factors but also with acquired factors such as smoking and alcohol history, blood pressure, blood glucose, and blood lipid levels. Ultimately, these factors manifest as inflammatory infiltration of the aneurysm wall and alterations in hemodynamic characteristics. Complex interactions exist among these risk factors, and different risk factors in the same patient may present contradictory indications regarding rupture risk, making quantitative assessment challenging. In traditional clinical practice, neurologists and neurosurgeons often rely on personal experience or simple assessment tools, such as the PHASES score, to guide treatment decisions. Consequently, significant discrepancies in assessment exist among physicians across different regions, with varying levels of seniority and professional backgrounds. Erroneous decision-making not only increases health risks for patients—leading to overtreatment or triggering preventable cerebral hemorrhage events—but also exacerbates the psychological and financial burden on patients’ families and strains societal medical resources.

《UKnow^®“Risk” Intracranial Aneurysm Assistant Evaluation Software innovatively applies AI technology to the treatment decision-making process. In a single-center, small-sample, prospective, self-controlled study conducted at Beijing Tiantan Hospital, Capital Medical University, the software-assisted approach improved physicians’ decision-making accuracy for stable aneurysms by 32%, significantly reducing surgical risks associated with overtreatment of stable aneurysms and expected to save tens of billions of yuan in medical expenditures, thereby delivering substantial health economic value. For unstable aneurysms, decision-making accuracy improved by nearly 20%, reducing the likelihood of misdiagnosis in such patients, thus preventing the significant risks and poor outcomes associated with aneurysm rupture and safeguarding patient safety. The retrospective clinical study results related to this software have been incorporated into the “Chinese Guidelines for Diagnosis and Treatment of Unruptured Intracranial Aneurysms 2021,” and the aforementioned latest prospective clinical study was published in the Chinese Journal of Neurosurgery in November 2022.

This time, Union Strong^®Another Blockbuster Product, "UKnow"^®“Risk” Intracranial Aneurysm Auxiliary Assessment Software has been approved for inclusion in the National Medical Products Administration’s Special Review Procedure for Innovative Medical Devices. This approval not only signifies recognition of the product’s global innovativeness, leading-edge status, and significant clinical value, but also marks a generational leap in AI-assisted technology—from the initial 1.0 stage of morphological diagnosis based on single-modality imaging, through the 2.0 stage of functional diagnosis based on single-modality imaging, to the groundbreaking 3.0 stage characterized by AI-driven decision-making and assessment using multimodal follow-up data. By Union Strong^®China’s original medical AI software, represented by these innovations, is achieving leapfrog development, seizing a global leading position, and ushering in a new chapter for medical AI!

Such AI-driven decision-support software is not only applicable to selecting optimal treatment plans and surgical timing for patients undergoing surgical intervention within hospital settings, as well as conducting annual online and offline follow-up assessments for those receiving conservative management, but can also be further utilized for early disease screening and assessment among high-risk sub-health populations during health check-ups. In the future, it holds promise for integration with insurance products such as health insurance and condition-specific coverage, thereby demonstrating broader and more clearly defined commercialization potential.