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Lehi Today
By the People, for the People
Lumea's IMS Viewer+™ Achieves CE Marking Under IVDR, Expanding Clinical Use Across Europe
Lumea's browser-based diagnostic hub now CE marked for clinical use in Europe under new regulations.
Published on Feb. 24, 2026
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Lumea's Viewer+™ software has received CE marking under the new In Vitro Diagnostic Regulation (IVDR) in Europe, allowing the browser-based diagnostic hub to be used clinically across the continent. This milestone ensures European laboratories can adopt Lumea's technology to meet the more stringent regulatory requirements while benefiting from the platform's efficiency, quality, and workflow improvements.
Why it matters
The transition from the previous In Vitro Diagnostic Medical Devices Directive (IVDD) to the new IVDR has created compliance challenges for many European labs, as legacy software often doesn't meet the updated standards. Lumea's IVDR-cleared Viewer+ provides a solution that enables uninterrupted diagnostic services while ensuring full regulatory compliance.
The details
Lumea's Viewer+™ software offers a robust suite of tools tailored to the modern pathologist's needs, including high-quality whole slide imaging, comprehensive case management, integrated diagnostic tools, and instant second opinion capabilities. The platform is designed to boost efficiency, with pathologists able to sign out cases up to 50% faster while keeping the entire slide image in view.
- Lumea's Viewer+™ software received CE marking under IVDR on February 18, 2026.
- The new In Vitro Diagnostic Regulation (IVDR) went into effect in the EU in May 2022, replacing the previous IVDD.
The players
Lumea
A company powering efficient, affordable, and accessible digital pathology through simplified, workflow-driven innovation with both tissue-handling technology and a best-in-class viewer with AI-driven workflows. Lumea is the U.S. leader in primary clinical digital pathology, processing the highest volume of digital cases nationwide.
Chelsea Sowards
Chief Commercial Officer at Lumea.
What they’re saying
“CE marking for Viewer+ enables Lumea to accelerate international growth and extend our digital pathology platform beyond the U.S. This milestone ensures European customers can confidently adopt our technology and realize efficiency, quality, and workflow benefits today.”
— Chelsea Sowards, Chief Commercial Officer (EINPresswire)
The takeaway
Lumea's IVDR-cleared Viewer+ platform provides a solution for European laboratories navigating the transition to the new, more stringent IVDR requirements, ensuring uninterrupted diagnostic services and full regulatory compliance while delivering efficiency, quality, and workflow improvements.
