Recognition places Lumea among elite global winners including Medtronic and Thermo Fisher Scientific in one of digital health’s most competitive annual programs
LEHI, UT, UNITED STATES, May 14, 2026 / — Lumea, the U.S. leader in primary clinical digital pathology, today announced it has been named the winner of the “Best New Biopsy Technology Solution” award in the 2026 MedTech Breakthrough Awards program. The annual program, now in its tenth year, received more than 5,000 nominations from digital health and medical technology companies across the globe, making this year’s competition among the most rigorous in the program’s history.
MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies, and products in the global digital health and medical technology market, selected Lumea from thousands of competing entries based on innovation, design, performance, and overall market impact.
“Being recognized by MedTech Breakthrough alongside companies like Medtronic, Boston Scientific, and Thermo Fisher Scientific validates what our clinical partners have known for years,” said James Thackeray, CEO of Lumea. “The formalin jar has been the standard in biopsy collection for decades — a reliable workhorse, but one designed long before digital pathology existed. We questioned it. The BxBoard® exists because we recognized that the container is just as important as the needle — and that fixing the pre-analytical stage was the missing piece that digital pathology needed to deliver on its clinical promise.”
Lumea’s tissue-handling technology was developed to address the pre-analytical failures that have historically limited digital pathology’s clinical impact. The BxBoard replaces the standard formalin jar, where delicate biopsy cores can coil, fragment, and lose anatomical orientation, with a transport system featuring site-specific lanes that hold cores flat, straight, and properly oriented throughout fixation and laboratory processing.
The BxBoard uses absorption fixation rather than traditional immersion which prevents the autolysis and over-fixation common in high-volume specimen jars. For urological diagnostics, where knowing the proximal versus distal end of a core is critical for surgical planning, the BxBoard also ensures the pathologist sees a true representation of the tissue as it existed in the patient.
Clinical validation across more than two million specimens has documented a 2.1x reduction in cancelled tests due to QNS or RNA degradation, an 83% reduction in collection containers per case, and a 28% increase in core length. A standard 12-core prostate biopsy that previously required 12 separate jars and 12 separate labels is consolidated into two BxBoards — dramatically lowering the risk of mislabeling and specimen mix-ups at the point of care.
“Every cancelled test due to QNS represents a patient who has to wait longer, or worse, a lesion that gets missed,” said Bianca Collings, Chief Marketing Officer of Lumea. “A 2.1x reduction in cancelled tests is not a lab efficiency number — it is a patient outcome number. That is what this award represents, and that is what our team has been working toward.”
The 2026 MedTech Breakthrough Awards program evaluated submissions across categories spanning medical devices, health information technology, patient engagement, telemedicine, electronic health records, clinical administration, and more. Additional 2026 winners include Noom, Teladoc, DocGo, Zimmer Biomet, CVS Health, Lyra Health, Elsevier, Medidata, IQVIA, PointClickCare, Canon Medical Systems, and Alcon/Novartis.
Lumea’s Viewer+™ digital pathology platform holds FDA 510(k) clearance for primary clinical diagnosis and CE marking under the EU’s In Vitro Diagnostic Regulation (IVDR) for clinical use across Europe. The company has been recognized by Inc. 5000 as one of the fastest-growing private companies in America, named to the Utah Business Fast 50, and previously honored as Healthcare Tech Innovator of the Year by Global Health and Pharma.
About Lumea
Lumea is a healthcare technology company redefining cancer diagnostics through specialty-integrated workflows purpose-built to transform the diagnostic journey. By reimagining the workflow rather than simply digitizing it, Lumea supports 40% of the U.S. outpatient prostate market and delivers a proven 18.79% increase in cancer detection rates, with national leadership in primary digital diagnostics across gastroenterology and dermatology. This specialty-driven approach prioritizes the people behind every diagnosis, positioning Lumea as the core system guiding critical treatment decisions when they matter most.
About MedTech Breakthrough
MedTech Breakthrough is an independent market intelligence organization that recognizes the top companies, technologies, and products in the global digital health and medical technology market. The annual MedTech Breakthrough Awards program provides a comprehensive analysis of the digital health and medical technology industry and honors innovation and performance across the full landscape of digital health technologies. For more information, visit medtechbreakthrough.com.
