First AI MRI Software for Early Alzheimer Diagnosis Granted NMPA Class III Approval: A Milestone for Early Detection

According to the official website of the National Medical Products Administration (NMPA), the software "Yiwei Brain Doctor" (Dr.Brain), developed by Yiwei Medical, has officially received its Class III Medical Device Registration Certificate. This marks the world's first approved AI software dedicated to assisting in the assessment and diagnosis of Alzheimer's Disease (AD) via magnetic resonance imaging (MRI).

This achievement represents China's first Class III certificate for AD software, signaling that AI technology has entered a practical implementation phase in brain structure analysis and establishing Yiwei Medical as a global leader in medical AI.

Clinical Validation Highlights:

Clinical trials were led by top Class 3A hospitals in China, including teams headed by President Lu Jie at Xuanwu Hospital (Capital Medical University), Director Liu Jun at Xiangya Second Hospital, and Director Yang Yunjun at the First Affiliated Hospital of Wenzhou Medical University.

High Precision: Scientific validation demonstrated that the AI software achieves sensitivity and specificity exceeding 90% in independent diagnosis.

Clinical Value: The tool significantly outperforms standard diagnostic accuracy, effectively helping doctors identify AD at its earliest stages.

Key Technological Innovations:

Developed under international and national guidelines (including IWG-1, NIA-AA, and Chinese diagnostic frameworks):

Clear Visualization and Precise Measurement: Provides high-resolution distinction between cerebral grey and white matter. It accurately measures key brain structures such as the hippocampus and amygdala while clearly depicting sulcal widening and ventricular enlargement.

Holistic Assessment via Deep Learning: Beyond basic shape and volume metrics, the deep learning model incorporates high-dimensional features like voxels, regional associations, and textures to deliver a comprehensive evaluation for early screening.

Current AD Landscape and Clinical Challenges

Increasing Aging Population and Younger Onset Trend:

While the majority of newly diagnosed AD patients in China are aged 60–79 (62.1%), patients under 60 account for 21.3%. This is noticeably higher than the global average of 5–10% for early-onset AD, highlighting a growing impact on the working-age population.

Heavy Economic Burden:

China currently has over 20 million AD patients, generating an economic cost exceeding 3.2 trillion RMB annually.

The Essential Solution: Early Screening, Diagnosis, and Treatment:

Approved AD therapies globally are most effective in early-stage patients to delay disease progression. While structural MRI is the preferred imaging modality, early subtle changes are often difficult to detect visually. AI algorithms enable clinicians to capture micro-level structural alterations early, reshaping future AD diagnostic workflows.

Strong Policy Support:

The initiative aligns with official directives from the National Health Commission (NHC) on dementia prevention (2023–2025) and digital healthcare objectives under China's 14th Five-Year Plan.

Platform Overview: Yiwei Brain Doctor (Dr.Brain)

Yiwei Brain Doctor is an AI-powered diagnostic and analysis platform focused on central nervous system diseases. Built on a proprietary brain MRI database covering Chinese populations across all age groups, it rapidly evaluates structural brain changes, white matter lesions, microbleeds, and cerebral blood flow.

Core Advantages:

Ultra-Early Diagnosis: Detects subtle structural changes invisible to the naked eye, opening an earlier diagnostic window.

Largest Chinese Brain Database: Contains over 250,000 cases sourced from top hospitals, spanning ages 1 to 100.

Comprehensive Segmentation: Evaluates 100 fine brain regions and 165 indicators with millimeter-level precision.

Practical Application:

The software is deployed in leading medical institutions such as Beijing Hospital and Shenzhen Kangning Hospital. It facilitates early screening and intervention, slows neurodegeneration, improves patient quality of life, and reduces healthcare costs for families and society.

Leadership Vision

Dr. Silun Wang, CEO and Founder of Yiwei Medical:

"Securing the world's first NMPA Class III certificate for an AD MRI AI-assisted diagnostic tool represents the dedication of countless individuals. For Yiwei, it is both official recognition and encouragement. The Class III approval is only the starting point for medical AI commercialization, and the journey ahead remains long.

The core value of medical AI lies in meeting clinical needs. Focusing on clinical utility and leveraging AI to empower healthcare has always been our foundation and will remain our core mission.

Moving forward, Yiwei Medical will continue to advance its technical capabilities, optimize product performance, and enhance clinical value to deliver more precise, intelligent, and safe medical solutions for Alzheimer's patients."