WORK Medical Receives Regulatory Approval for AI-Powered Blood Cell Morphology Analyzer
核心洞察
WORK Medical Technology Group's subsidiary Hunan Saitumofei Co., Ltd. (搜索) received manufacturing approval from the Hunan Provincial Medical Products Administration for its Class II AI-Automated Human Blood Cell Morphology Analyzer (搜索).
The device combines high-speed digital imaging, deep-learning algorithms, and fully automated workflow to identify and analyze white blood cells, red blood cells, and platelets in peripheral blood smears.
Manufacturing is scheduled to begin in the first half of 2026, with the analyzer expected to become standard equipment in hematology and oncology departments at tertiary hospitals and primary-care laboratories.
WORK Medical Technology Group LTD (搜索) announced that its subsidiary, Hunan Saitumofei Co., Ltd. (搜索), has received manufacturing approval from the Hunan Provincial Medical Products Administration for its Class II medical device, the Artificial Intelligence-Automated Human Blood Cell Morphology Analyzer. This regulatory approval represents a milestone in WORK Medical's research and development strategy and is expected to position the Company's new AI-driven device as a key growth catalyst.
Device Technology and Capabilities
The analyzer consists of a main unit and embedded analysis software. The main unit integrates an optical imaging system, sample-handling module, barcode scanner, automatic oil-immersion unit, control board, and protective housing. It performs white blood cell differential counts on human blood smears and quantifies morphological parameters of red blood cells and platelets, supporting clinicians in cell morphology screening.
Powered by advanced AI automation, the analyzer combines high-speed digital imaging, deep-learning algorithms, and a fully automated workflow to identify, pre-classify, and describe the morphology of white blood cells, red blood cells, and platelets in peripheral blood smears. The device is designed to enhance efficiency, consistency, and accuracy in microscopic examinations while reducing manual workload and operational costs.
Manufacturing Timeline and Market Positioning
The analyzer is scheduled to begin manufacturing in the first half of 2026. According to CEO and Chairman Shuang Wu, the device has progressed from an auxiliary image-reading tool into a fully automated, standardized, and remotely accessible core testing platform.
"This new analyzer integrates cutting-edge AI technology into traditional medical testing, improving consistency, efficiency, and accuracy while minimizing manual intervention and associated costs," Wu commented. "With continuous AI-algorithm iteration and pipeline integration, it is expected to become standard equipment in hematology and oncology departments at tertiary hospitals and primary-care laboratories."
Clinical Applications and Market Impact
The analyzer is aimed to provide support for early screening of blood disorders, quality-control enhancement, and labor-cost optimization. Wu expressed optimism about the product line's growth and its revenue potential for the Company.
WORK Medical Technology Group LTD (搜索), through its subsidiary Work (Hangzhou) Medical Treatment Equipment Co., Ltd. and its subsidiaries in China, is a supplier of medical devices that develops and manufactures Class I and II medical devices. The Company has a diverse product portfolio comprising 21 products, with all products sold in 34 provincial-level administrative regions in China and 15 products sold in more than 30 countries worldwide. The Company has registered 17 products with the U.S. Food and Drug Administration, allowing their products to enter the U.S. market.