Lumea’s Digital Diagnostic Suite™ (Viewer+™) Receives FDA 510(k) Clearance for Clinical Diagnosis

Lumea, a leader in digital pathology solutions, is proud to announce that its Viewer+™ software has received FDA 510(k) clearance, solidifying its role as a cutting-edge, centralized diagnostic hub for pathologists. This clearance ensures that Viewer+, our Digital Diagnostic Suite™, meets the highest standards of safety and effectiveness, allowing it to be used for primary diagnosis in clinical settings.

Precision in medicine isn’t a luxury—it’s a necessity. Pathology data informs nearly 70% of medical decisions*, yet inconsistencies in tissue handling can compromise accuracy. Lumea’s holistic workflow solutions address these challenges by optimizing every step of the pathology journey, from tissue collection to diagnosis. Viewer+ plays a pivotal role in this workflow, offering pathologists a seamless digital experience that enhances efficiency and diagnostic accuracy.

With FDA clearance, Viewer+ sets a new standard in digital pathology, offering a robust suite of tools tailored to the modern pathologist’s needs, including:

– Views Better Than Glass Slides: Digital slide images rendered with precision so high that they are visually identical to, and often better than, 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 Diagnostic 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.

– Seamless AI & Ancillary Testing Integration: A robust open marketplace enables access to third-party AI solutions and digital ancillary test ordering, further enhancing diagnostic capabilities.

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. The software even supports iPad functionality, allowing for flexibility in workflows and remote diagnostics.

“The FDA clearance of Viewer+ is great recognition of the exceptional quality of Lumea’s digital pathology solution. With this approval, we’re not just offering another digital pathology viewer—we’re providing an all-in-one diagnostic powerhouse that transforms the way pathologists work, improving efficiency, accuracy, and ultimately, patient outcomes,”

said Andy Ivie, Lumea CTO.

With Viewer+, pathologists no longer need to rely on stacks of slides, multiple screens, and fragmented workflows. Instead, they have everything they need—on one screen, in one intuitive system.

To learn more about how Viewer+ is setting a new standard in digital pathology, visit LumeaDigital.com/viewerplus, or visit USCAP booth #901 for a demo and get a free pair of Histosocks! .