Yiwei Medical Becomes China's Only AI Company with NMPA Class III Certifications in Both Alzheimer’s Disease and Stroke Diagnosis

According to the official website of China's National Medical Products Administration (NMPA),Yiwei Medical’s AI-powered stroke diagnostic software—RuiNao ICH Intracranial Hemorrhage Triage Software—has officially received NMPA Class III certification!This product enables rapid, intelligent analysis of non-contrast cranial CT images, providing quick quantitative assessment of intracranial hemorrhage, comprehensive identification of hematoma locations, and precise calculation of hematoma volume. It efficiently assists clinical physicians in making timely diagnostic and therapeutic decisions, thereby effectively reducing patient treatment risks and time costs.

To date, Yiwei AI’s stroke products have obtained one Class III medical device registration certificate from China’s NMPA, three Class II certificates, one U.S. FDA 510(k) clearance, and EU CE certification, ranking among the industry leaders.

Yiwei Medical’s stroke care product has successfully passed a multicenter clinical trial jointly conducted by senior teams from multiple large tertiary Grade A hospitals across China, including Zhujiang Hospital of Southern Medical University, Shenzhen Hospital of Peking University, and Wuxi No. 2 People’s Hospital. Through rigorous, professional, and scientifically robust research and clinical validation, the sensitivity and specificity for ICH hemorrhage triage both exceeded 96%, significantly surpassing the target values established for the clinical trial.

The approval of Yiwei Medical’s Class III medical device certificate for its brain-related product underscores the full recognition and validation of its product technology’s reliability, accuracy, and rigor in clinical trials. This marks the second Class III certificate approved by the National Medical Products Administration (NMPA) in the field of neurological disorders within the past six months, following Yiwei Medical’s earlier receipt of the world’s first Class III certificate for an AI software designed to assist in the MRI-based diagnosis of Alzheimer’s disease (AD). With this achievement, Yiwei Medical has become the only brain science AI company in China to hold NMPA Class III certificates in both neurodegenerative diseases and cerebrovascular diseases, solidifying its position as an industry benchmark in the fields of brain science and artificial intelligence in healthcare.

According to the World Health Organization, one in every six people worldwide is at risk of suffering a stroke; every six seconds, one person dies from a stroke, and every six seconds, another is permanently disabled by it. In China, a stroke occurs every 12 seconds, and a stroke-related death occurs every 21 seconds. Each year, there are 2 to 2.5 million new stroke cases. Stroke has become the leading cause of death and disability among adults in China. Research from the University of California shows that for every minute treatment is delayed after a stroke, 1.9 million neurons in the brain die. Damaged neurological functions are difficult to self-repair; therefore, for stroke patients, time is life.

Acute intracranial hemorrhage carries a case fatality rate of 30%–40%. Rapid and accurate diagnosis within the golden time window is critical for saving patients’ lives. The “Chinese Guidelines for Imaging Applications in Cerebrovascular Diseases (2019)” state that non-contrast head CT is currently the clinical “gold standard” for confirming acute intracerebral hemorrhage, directly influencing subsequent treatment and prognostic plans. However, precise quantification of hematomas based on imaging remains challenging, and small hemorrhages are difficult to detect. Diagnosis heavily relies on the experience of senior physicians, representing a major pain point in the imaging diagnosis of intracerebral hemorrhage.Therefore, rapid and precise detection of bleeding foci for accurate diagnosis and appropriate treatment remains a major clinical challenge.

Yiwei - Ruinao

One-Stop AI-Assisted Diagnostic Platform for the Acute Phase of Stroke

 RuiNao ICH - Intracerebral Hemorrhage Diagnostic Classification

RuiNao CTA - Assisted Diagnostic Analysis

RuiNao CTP - Fully Automated Tissue Window Assessment

RuiNao MRP - Fully Automated Tissue Window Assessment

Yiwei-Ruinao One-Stop AI-Assisted Diagnostic Platform for Acute Stroke: Automatically generates analysis results within 3 minutes, reducing post-processing and image interpretation time. It rapidly and accurately provides core infarct zone and ischemic penumbra visualization, automatic mismatch value calculation, and multi-parametric mapping for localization, quantification, and qualitative assessment. This offers objective, quantitative surgical indications for clinical ultra-window interventional therapy, supporting precise decision-making in stroke diagnosis and treatment. The platform’s recently approved Class III medical device certification includes ICH hemorrhage typing, which automatically locates bleeding sites and quantitatively analyzes hemorrhagic lesions. It also provides critical value alerts for patients with suspected intracranial hemorrhage, facilitating efficient triage of stroke patients and significantly improving diagnostic and therapeutic efficiency.

Dr. Wang Silun, CEO and Founder of Yiwei Medical

Dr. Wang Silun stated: Yiwei Medical will continue to leverage its core technological advantages, focusing on the integration of “AI technology and clinical needs.” By deeply learning from and accumulating data on stroke diagnosis and treatment, the company aims to continuously shorten the time required for stroke care, making the entire process more precise and efficient, thereby providing new support for stroke diagnosis and treatment.

In the future, Yiwei Medical will continue to actively leverage its technological advantages, constantly optimize product features, and enhance the clinical value of its products. This will enable more precise, intelligent, and safe medical care, allowing a greater number of patients with brain disorders to benefit from and enjoy the conveniences brought by technology. By writing a new chapter in the development of AI for medical imaging, Yiwei Medical aims to build a solid foundation for safeguarding the brain health of the Chinese population.