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WORK Medical Technology Group LTD Subsidiary Obtains Manufacturing Approval for Its AI-Automated Blood Cell Morphology Analyzer

Key Takeaway: WORK Medical Technology Group's subsidiary has received manufacturing approval for its AI-automated blood cell morphology analyzer from the Hunan Provincial Medical Products Administration. This Class II medical device is designed to improve the efficiency and accuracy of blood cell analysis, supporting clinicians in diagnosing blood disorders. The device is expected to begin manufacturing in the first half of 2026, marking a significant advancement in the company's product offerings.

Market Sentiment Analysis

POSITIVE FACTORS

  • Approval of a new AI-automated blood cell analyzer.
  • Expected to enhance efficiency and accuracy in medical testing.
  • Potential for significant revenue growth for WORK Medical.
  • Integration of advanced AI technology into traditional medical practices.

Full Press Release Details

Hangzhou, China, Dec. 29, 2025 (GLOBE NEWSWIRE) -- WORK Medical Technology Group LTD (Nasdaq: WOK) (“WORK Medical” or the “Company”), a supplier of medical devices in China, through its subsidiary, Work (Hangzhou) Medical Treatment Equipment Co., Ltd. and its subsidiaries in China, today announced that its subsidiary, Hunan Saitumofei Co., Ltd., has received manufacturing approval from the Hunan Provincial Medical Products Administration for its Class II medical device, the Artificial Intelligence (“AI”)-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.
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 analyzer, scheduled to begin manufacturing in the first half of 2026, is designed to enhance efficiency, consistency, and accuracy in microscopic examinations while reducing manual workload and operational costs.
Mr. Shuang Wu, the Chief Executive Officer and Chairman of the Board of Directors of WORK Medical, commented: “This new analyzer integrates cutting-edge AI technology into traditional medical testing, improving consistency, efficiency, and accuracy while minimizing manual intervention and associated costs. The device has progressed from an auxiliary image-reading tool into a fully automated, standardized, and remotely accessible core testing platform. 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, and is aimed to provide support for early screening of blood disorders, quality-control enhancement, and labor-cost optimization. We are optimistic about this product line’s growth and its revenue potential for the Company.”
About WORK Medical Technology Group LTD
WORK Medical Technology Group LTD, 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 and sells Class I and II disposable medical devices through operating subsidiaries in China. The Company has a diverse product portfolio comprising 21 products, including customized and multifunctional masks and other medical consumables. All the products have been sold in 34 provincial-level administrative regions in China, with 15 of them sold in more than 30 countries worldwide. The Company has received a number of quality-related manufacturing designations and has registered 17 products with the U.S. Food and Drug Administration allowing their products to enter the U.S. market. For more information, please visit the Company’s website:https://www.workmedtech.com/corporate.
Forward-Looking Statements
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any forward-looking statements in this press release are based on the Company’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results set forth in the Company’s annual report on Form 20-F and other documents filed by the Company with the U.S. Securities and Exchange Commission. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
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Frequently Asked Questions

What approval did WORK Medical's subsidiary receive?

Hunan Saitumofei Co., Ltd. received manufacturing approval for an AI-automated blood cell analyzer.

What is the purpose of the AI blood cell analyzer?

The analyzer enhances efficiency and accuracy in analyzing blood cell morphology.

When will the manufacturing of the analyzer begin?

Manufacturing of the AI blood cell analyzer is scheduled to start in the first half of 2026.

What technology does the analyzer utilize?

The analyzer uses advanced AI automation and deep-learning algorithms for analysis.

What benefits does the new analyzer provide?

It improves consistency, reduces manual workload, and supports early screening of blood disorders.

Last updated: Dec 29, 2025