Clarius vs ScreenPoint Transpara
ScreenPoint's Transpara supports cancer detection on 2D FFDM and 3D DBT mammograms, and breast screening services reading mammograms are its customers. openFDA lists eight Transpara decisions, the latest in August 2026. The company raised EUR 13.6M in April 2026.
The vendor says Transpara was the software in MASAI, a randomized mammography screening trial in Sweden. The 2026 Lancet interval-cancer analysis of MASAI, academic work from Lund University, reported sensitivity of 80.5% with AI support against 73.8% for standard double reading, at 98.5% specificity, across more than 105,000 women. The vendor separately claims a 29% cancer detection increase and a 44% workload reduction.
The vendor says Clarius Prostate AI returns TRUS and TAUS prostate volume, and openFDA holds it as K243853. That suits a urology practice. Prostate volume and breast cancer detection are different clinical tasks on different devices, so a urology practice and a breast screening service buy separately.
Radiology · Reviewed November 2, 2026

Clarius
by Clarius Mobile Health
Wireless handheld ultrasound scanners with FDA-cleared onboard AI tools for bladder, prostate, OB and cardiac measurement.

ScreenPoint Transpara
by ScreenPoint Medical
Transpara Breast AI: cancer detection support, density and risk tools for 2D and 3D mammograms.
When to pick each one
Clarius
- Vendor says Prostate AI returns TRUS and TAUS volume
- FDA decision K243853 covers Clarius Prostate AI
ScreenPoint Transpara
- Works with 2D FFDM and 3D DBT mammography systems
- Eight Transpara 510(k) decisions, latest August 2026
- Vendor says Transpara was the software in MASAI
Score
Each row shows points earned of points available under the published rubric.
Clarius
53of 100
ScreenPoint Transpara
56of 100
| Dimension | Clarius | ScreenPoint Transpara | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| 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 | 12.7 / 18.2 | 12.7 / 18.2 | 0 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 7.8 / 7.8 | 0 |
| Funding & adoption signal | 3 / 12 | 6 / 12 | -3 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Clarius
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
ScreenPoint Transpara
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Virtual demo and contact only. |
Evidence
Clarius
FDA decisions
K253593 (opens in new tab)510(k)2026-03-02
Clarius Ejection Fraction AI
K250226 (opens in new tab)510(k)2025-05-08
Clarius Median Nerve AI
K243853 (opens in new tab)510(k)2025-04-16
Clarius Prostate AI
K233955 (opens in new tab)510(k)2024-06-14
Clarius OB AI
K232257 (opens in new tab)510(k)2023-11-13
Clarius Bladder AI
Show 1 more
K222406 (opens in new tab)510(k)2023-01-23
Clarius AI
Peer-reviewed
3 PubMed records name Clarius.
- Can handheld ultrasound probes reliably measure transabdominal prostate and bladder volumes? A prospective randomized point-of-care ultrasound study. (opens in new tab)
- Artificial Intelligence-Assisted Lung Ultrasound for Pneumothorax: Diagnostic Accuracy Compared with CT in Emergency and Critical Care. (opens in new tab)
- Validation of Handheld Ultrasound Devices for Point of Care Use in Rheumatology Study- Focus on Synovitis, Doppler Activity, Erosions, and Tendon Lesions. (opens in new tab)
ScreenPoint Transpara
FDA decisions
K260898 (opens in new tab)510(k)2026-08-14
Transpara (2.1.0)
K241831 (opens in new tab)510(k)2024-11-25
Transpara (2.1.0)
K232096 (opens in new tab)510(k)2023-12-11
Transpara Density 1.0.0
K221347 (opens in new tab)510(k)2022-08-03
Transpara 1.7.2
K210404 (opens in new tab)510(k)2021-06-02
Transpara 1.7.0
Show 3 more
K193229 (opens in new tab)510(k)2020-03-05
Transpara
K192287 (opens in new tab)510(k)2019-12-10
Transpara
K181704 (opens in new tab)510(k)2018-11-21
Transpara
Peer-reviewed
3 PubMed records name ScreenPoint Transpara.
- Interval cancer, sensitivity, and specificity comparing AI-supported mammography screening with standard double reading without AI in the MASAI study: a randomised, controlled, non-inferiority, single-blinded, population-based, screening-accuracy trial. (opens in new tab)
- Screening performance and characteristics of breast cancer detected in the Mammography Screening with Artificial Intelligence trial (MASAI): a randomised, controlled, parallel-group, non-inferiority, single-blinded, screening accuracy study. (opens in new tab)
- Artificial intelligence-supported screen reading versus standard double reading in the Mammography Screening with Artificial Intelligence trial (MASAI): a clinical safety analysis of a randomised, controlled, non-inferiority, single-blinded, screening accuracy study. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Clarius | ScreenPoint Transpara |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | n/a | NL |
Scroll horizontally to see both columns.
Common questions
Open the full radiology comparison
Acute-care triage, mammography screening, CCTA plaque analysis, mobile MRI. 30+ FDA-cleared platforms across stroke, oncology, cardiac. Enterprise sales only — we compared what's deployed where.
