Hangzhou, China – December 2025 — WORK Medical Technology Group LTD (Nasdaq: WOK) today announced that its subsidiary, Hunan Saitumofei Co., Ltd., has received manufacturing approval from the Hunan Provincial Medical Products Administration for its Class II Artificial Intelligence (AI)-Automated Human Blood Cell Morphology Analyzer, marking a key regulatory milestone in the company’s AI-driven diagnostics strategy.
The approved system integrates advanced optical imaging with deep-learning algorithms to automate blood cell morphology analysis. Designed to deliver accurate white blood cell differential counts alongside quantitative assessments of red blood cell and platelet morphology, the analyzer aims to enhance diagnostic consistency, reduce manual interpretation, and improve laboratory throughput.
The AI-Automated Human Blood Cell Morphology Analyzer combines a high-resolution imaging unit, intelligent analysis software, automated sample handling, barcode identification, and oil-immersion capabilities into a unified diagnostic platform. By replacing labor-intensive manual smear reviews with standardized AI-based analysis, the system is positioned to support early screening and monitoring of hematologic disorders while significantly lowering operational burden in clinical laboratories.
Manufacturing of the analyzer is expected to commence in the first half of 2026, enabling broader commercial deployment across hospital laboratories and diagnostic centers.
Shuang Wu, Chief Executive Officer and Chairman of WORK Medical Technology Group, said:
“This manufacturing approval represents a critical step in advancing AI from an auxiliary diagnostic tool to a fully automated and standardized core testing platform. Our AI-Automated Blood Cell Morphology Analyzer reflects our commitment to improving diagnostic efficiency, quality control, and scalability while supporting the evolving needs of modern clinical laboratories.”
About WORK Medical Technology Group LTD
WORK Medical Technology Group LTD, through its operating subsidiaries including Work (Hangzhou) Medical Treatment Equipment Co., Ltd. and Hunan Saitumofei Co., Ltd., develops, manufactures, and commercializes Class I and Class II medical devices. The company’s portfolio includes automated diagnostic systems and disposable medical consumables distributed across China and international markets.
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