IVD China last week: Siemens Healthineers, Snibe, Fosun Diagnostics, Medconn Diagnostics

Siemens Healthineers Officially Launches First APAC Production Line for Laboratory Diagnostics Equipment

Siemens Healthineers' first domestically produced high-end laboratory diagnostics system—the Atellica automated biochemical and immunoassay analyzer—has officially commenced production at its Shanghai R&D and manufacturing base. This also marks the company's first laboratory diagnostics instrument production line in the Asia-Pacific region.

The locally manufactured product received NMPA approval in April this year. With this production launch, Siemens Healthineers has achieved full-range domestic manufacturing capabilities across major product lines, including large imaging diagnostics equipment, clinical interventional therapy devices, and laboratory diagnostics systems.

Snibe's Biochemistry Analysis System Receives CDC Certification

Recently, Shenzhen New Industries Biomedical's (SNIBE) Total Cholesterol (TC) assay obtained certification from the CDC-CRMLN (Cholesterol Reference Method Laboratory Network). This certification confirms that the assay meets the performance standards set by the U.S. National Cholesterol Education Program (NCEP) and is traceable to international reference methods, serving as strong validation of SNIBE's high-quality reagents.

Fosun Diagnostics and Siemens Healthineers Unveil First Joint Innovation to Foster Localized Collaborative Ecosystem

As Siemens Healthineers launched its first domestically produced high-end diagnostic system, the Atellica automated biochemical and immunoassay analyzer, Fosun Diagnostics officially announced a strategic partnership with the company to introduce their first collaborative product—a locally developed biochemical reagent solution. This collaboration marks a new phase in deepening localized innovation and enhancing the accessibility of high-end domestic diagnostic products between Chinese healthcare technology leaders and global giants. By integrating technology, production capacity, and global resources, the two parties will jointly drive innovation and advancement in the in vitro diagnostics (IVD) sector.

Medconn Diagnostics Secures First FDA Approval

Recently, the U.S. Food and Drug Administration (FDA) officially granted 510(k) clearance to Medconn Diagnostics' independently developed MQ-3000/MQ-3000PT Glycated Hemoglobin (HbA1c) Testing System. This marks the first FDA-registered HbA1c detection device from China based on High-Performance Liquid Chromatography (HPLC) technology, representing a historic breakthrough for domestically developed HPLC technology in the in vitro diagnostics (IVD) field.