- No public price. The site shows no plan, billing period or trial.
- Not disclosed
- Not disclosed
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- US
Pathology
Lumea BxChange
by Lumea · US
Digital pathology for urology, dermatopathology and GI: FDA-cleared slide viewer Viewer+, lab software BxLink, tissue products and partner AI.
On this page
20/100Niche fit
- Regulatory & Compliance18/28
FDA cleared (1 K-number on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength0/28.8
No peer-reviewed coverage
- Vendor & Market3/18
Seed-stage or unfunded
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (1 K-number on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/14
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/8
None of the top-3 EHRs covered
- Bidirectional write-back0/4
No bidirectional write-back documented
- Peer-reviewed papers0/21
No peer-reviewed coverage
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal3/12
Seed-stage or unfunded
- Years in market0/6
Founded year not recorded
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
Digital pathology for urology, dermatopathology and GI: FDA-cleared slide viewer Viewer+, lab software BxLink, tissue products and partner AI.
No public price. The site shows no plan, billing period or trial.
Bottom line
Lumea, Inc., with an address in Lehi, Utah, sells digital pathology for specialty practices, focused on prostate biopsy, dermatopathology and gastroenterology. The package has four parts: tissue-handling products, the Viewer+ slide viewer, BxLink as a digitally enabled laboratory information system, and an open ecosystem of third-party AI. The FDA cleared Viewer+ in March 2025.
What does Lumea sell?
Lumea calls itself a specialty-specific digital pathology company and covers the path from biopsy to final report.
- Viewer+ displays whole slide images on any device.
- BxLink handles case intake, image routing, AI result integration, molecular test ordering and reporting.
- BxBoard, BxChip and BxCamera are tissue products for specimen handling.
Lumea says the parts are modular, so a practice can adopt the viewer alone and add the laboratory system later. Its integrations page lists Paige, Primaa, Mindpeak and AIRA Matrix as AI partners whose algorithms plug into the workflow.
What does the Viewer+ clearance cover?
Viewer+ is cleared under K242244, received by FDA on July 31, 2024 and decided on March 14, 2025, in the digital pathology image viewing category (product code QKQ). The clearance summary describes version 1.0.1 as a web-based viewer used with images from the Hamamatsu NanoZoomer S360MD scanner and limits it to formalin-fixed, paraffin-embedded slides. Frozen sections and cytology are outside it. An Innolitics summary of the filing says no clinical data were submitted.
Lumea's site says the viewer works with all major scanner manufacturers, while the clearance summary names the Hamamatsu model alone.
What does Lumea claim about results?
Lumea says it serves more than 40% of the US outpatient prostate cancer market and that GI Alliance adopted its viewer. It also claims return on investment within three months, a 19% increase in cancer detection and a 35% reduction in tissue fragmentation, and it publishes no method for those three figures.
What does Lumea cost?
Lumea's site carries no figures, trial or refund terms.
What does Lumea say about security?
Lumea describes the platform as "designed in line with" HIPAA and HITECH, with documentation on request. Its site does not mention SOC 2, HITRUST or a business associate agreement, and it refers to integration with third-party laboratory systems without naming any.
The verdict
Lumea is a specialty vendor with one FDA-cleared component, the viewer, and a workflow system and tissue products around it. A urology, dermatopathology or GI practice gets the chain from specimen to report from one company. A lab whose slides are frozen sections or cytology is outside the viewer's clearance, and so is a lab whose images come from a scanner other than the Hamamatsu NanoZoomer S360MD.
Editorial review last generated October 15, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Quote only | — | — | No public price. The site shows no plan, billing period or trial. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA 510(k) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
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