Lumea’s IMS Viewer+™ Achieves CE Marking Under IVDR, Expanding Clinical Use Across Europe

Lumea’s Viewer+™ software is now CE marked under IVDR for clinical use across Europe, making Lumea the most versatile diagnostic hub for the global market.

LEHI, UT, UNITED STATES, February 18, 2026 /EINPresswire.com/ -- Lumea’s Viewer+™ software is now CE marked under IVDR for clinical use across Europe, making Lumea the most versatile browser-based diagnostic hub for the global market.

Precision in medicine is a necessity. Pathology data informs nearly 70% of medical decisions, yet diagnostic quality is often hindered (or compromised) by a combination of inconsistencies in tissue handling and siloed digital tools. Lumea’s holistic workflow solutions and Viewer+ address these challenges by providing an optimized and unified path from tissue collection to diagnosis that ensures both precision and efficiency.

As European laboratories navigate the transition from IVDD compliance to the new In Vitro Diagnostic Regulation (IVDR) requirements, many face a “compliance cliff,” where legacy software and in-house developed tools don’t meet the new, more stringent requirements for clinical use. Lumea’s IVDR-cleared Viewer+ provides a safe harbor for these institutions, offering a globally validated platform that ensures uninterrupted diagnostic services and full regulatory compliance.

Chelsea Sowards, Chief Commercial Officer at Lumea, commented, “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.”

With CE marking under IVDR, Viewer+™ sets a new standard in global digital pathology, offering a robust suite of tools tailored to the modern pathologist’s needs, including:

- Highest Quality Whole Slide Images: Digital slide images are rendered with precision so high that they are visually equivalent to traditional microscope views.
- Comprehensive Case Management: Pathologists can manage slide orders, review gross images, access patient history, and track previous biopsy results—all in one place.
- Integrated Tools: All essential tools are built directly into the viewer, eliminating the need for multiple screens and manual test ordering.
- Instant Second Opinions: Pathologists can consult peers within and outside their network instantly, ensuring confident diagnoses.

Designed with efficiency and usability in mind, Viewer+ enables pathologists to sign out cases up to 50% faster while keeping the whole slide image always in view.

By combining regulatory rigor with an intuitive, high-performance diagnostic technology, Lumea ensures that laboratories can meet today’s demands while preparing for tomorrow’s innovations. This milestone reinforces Lumea’s commitment to empowering pathologists and improving patient outcomes worldwide.

About Lumea
Lumea is 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. As the U.S. leader in primary clinical digital pathology, processing the highest volume of digital cases nationwide, Lumea has set the standard for efficiency, quality, and premium cancer diagnostics. With a global presence spanning five continents, Lumea supports over half of the U.S. urology market and top dermatology and gastroenterology groups, optimizing tissue integrity, boosting detection rates, and delivering measurable ROI. By placing patients at the core, Lumea is transforming pathology for a more precise and efficient future. Learn more at lumeadigital.com.

About CE Marking Under IVDR
CE marking indicates that an in vitro diagnostic (IVD) device complies with the mandatory European In Vitro Diagnostic Regulation requirements, and that the device can be legally commercialized in the EU. The IVDR went into effect in May 2022, replacing the previous In Vitro Diagnostic Medical Devices Directive (IVDD). These new standards demand enhanced safety, performance, and technical documentation requirements that modernize and improve the reliability of diagnostic tests in the EU. For more information, see https://health.ec.europa.eu/medical-devices-sector/new-regulations_en.

Bianca Collings
Lumea
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