Tempus Digital Pathology vs Visiopharm
On prostate, Tempus holds the FDA record. Paige Prostate Detect was authorized under De Novo DEN200080 in September 2021 and is also CE-IVDR marked, and Tempus claims a 20% shorter reading time. A US lab adding second reads on prostate core biopsies picks Tempus once it confirms its scanner is on the supported list. Visiopharm lists prostate among its IVDR apps, but no Visiopharm clearance appears in the FDA database.
Visiopharm offers the broader diagnostic menu. Its homepage promises IVDR-certified apps for breast, lung and prostate biomarker assessment, and a 2025 paper measured its HER2 app against expert breast pathologists. Tempus's breast, GI and PanCancer tools are research use only.
A European lab that wants prostate scoring and breast biomarker scoring under IVDR from one vendor should go with Visiopharm. For that lab Tempus is the narrower buy, since only Prostate Detect is FDA-authorized and CE-IVDR.
Pathology · Reviewed November 1, 2026
Tempus Digital Pathology
by Tempus AI
Digital pathology AI from Paige, now part of Tempus: Paige Prostate Detect (FDA De Novo, CE-IVDR) plus research-use suites.
Visiopharm
by Visiopharm
Pathology image-analysis software with CE-IVD apps for breast, lung and prostate biomarkers and a research-use platform.
When to pick each one
Tempus Digital Pathology
- Prostate Detect authorized by FDA under De Novo DEN200080
- Vendor-claimed 20% shorter reading time
- Prostate Detect also CE-IVDR marked
Visiopharm
- Vendor-stated IVDR apps for breast, lung and prostate
- 2025 HER2-low agreement study
- Lymph-node metastasis app for H&E slides
Score
Each row shows points earned of points available under the published rubric.
Tempus Digital Pathology
38of 100
Visiopharm
43of 100
| Dimension | Tempus Digital Pathology | Visiopharm | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 0 / 18 | +18 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 0 / 21 | 21 / 21 | -21 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 7.8 / 7.8 | -7.8 |
| Funding & adoption signal | 12 / 12 | 6 / 12 | +6 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Tempus Digital Pathology
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price on the Tempus pages. |
Visiopharm
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Tempus Digital Pathology
FDA decisions
K241273 (opens in new tab)510(k)2025-01-09
Paige FullFocus
DEN200080 (opens in new tab)De Novo2021-09-21
Paige Prostate Detect
K201005 (opens in new tab)510(k)2020-07-15
Paige FullFocus
Visiopharm
FDA decisions
No FDA decision cited in our research as of October 20, 2026.
Peer-reviewed
5 PubMed records name Visiopharm.
- Inter-rater agreement of HER2-low scores between expert breast pathologists and the Visiopharm digital image analysis application (HER2 APP, CE2797). (opens in new tab)
- Clinical implementation of artificial-intelligence-assisted detection of breast cancer metastases in sentinel lymph nodes: the CONFIDENT-B single-center, non-randomized clinical trial. (opens in new tab)
- Head-to-Head Comparison of 2 Artificial Intelligence Tools for Detecting Lymph Node Metastases in Whole-Slide Pathology Images Within and Beyond Their Intended Use. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Tempus Digital Pathology | Visiopharm |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | US | DK |
Scroll horizontally to see both columns.
Common questions
Open the full pathology comparison
Digital pathology workflows with FDA-cleared cancer detection (prostate, breast, colon), IHC scoring (HER2, Ki67), and AI-powered image management. Tempus, PathAI, Proscia dominate.