- No public price. Virtual demo and contact only.
- Not disclosed
- Not disclosed
- —
- —
- NL
Radiology
ScreenPoint Transpara
by ScreenPoint Medical · NL
Transpara Breast AI: cancer detection support, density and risk tools for 2D and 3D mammograms.
On this page
42/100Competitive
- Regulatory & Compliance18/28
FDA cleared (8 K-numbers on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength20.5/26
3 peer-reviewed papers
- Vendor & Market6/18
Early-stage company
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (8 K-numbers 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 papers13/18
3 peer-reviewed papers
- RCT / meta-analysis / systematic review8/8
3 RCT/Meta-Analysis/Systematic Review
- Funding & adoption signal6/12
Early-stage company
- 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
Transpara Breast AI: cancer detection support, density and risk tools for 2D and 3D mammograms.
No public price. Virtual demo and contact only.
Bottom line
Transpara is a mammography AI from ScreenPoint Medical in Nijmegen, the Netherlands, for 2D and 3D screening exams. ScreenPoint says it was the AI in the MASAI randomized trial run by Lund University and published in the Lancet journals, and describes MASAI as the first randomized trial in breast AI. The FDA lists eight Transpara 510(k)s, the latest from August 2026, and the product is also CE marked. Breast screening programs and radiology groups are the buyers, and ScreenPoint quotes no price.
What does Transpara do?
ScreenPoint calls it "the industry-leading artificial intelligence" for 2D and 3D mammograms and describes it as a "second pair of eyes". Transpara Detection supports cancer detection on 2D full-field digital mammograms and 3D tomosynthesis, with single or double reading. A risk score drives triage of low-risk exams, which clinician testimonials on the vendor page praise. Transpara Density, cleared as K232096, assesses breast density. The family is now called Transpara Breast AI.
The company says the software is "vendor agnostic", works with whichever FFDM and DBT systems a site owns, and is trusted in more than 30 countries. It claims over 55 peer-reviewed publications.
What does the MASAI trial show?
ScreenPoint's page claims that in a randomized trial Transpara increased cancer detection by 29% and reduced reading workload by 44%. The trial is MASAI, a Swedish screening study, and three papers from it are in PubMed.
- Lancet Oncology, 2023 (PMID 37541274), compared AI-supported screen reading with standard double reading.
- Lancet Digital Health, 2025 (PMID 39904652) reported screening performance and the characteristics of the cancers detected in a randomized, controlled, parallel-group, non-inferiority study.
- The Lancet, 2026 (PMID 41620232) looked at interval cancers, sensitivity and specificity over more than 105,000 women. ScreenPoint reports a 12% lower interval cancer rate, and sensitivity of 80.5% against 73.8% for standard double reading at 98.5% specificity.
The 29% and 44% figures come from different analyses and are the vendor's, so they are not one result. The trial ran in a Swedish double-reading workflow with one vendor's software, and whether the same gains hold in US practice, where double reading is not routine, is a question the trial does not answer.
Who is ScreenPoint?
ScreenPoint Medical B.V. was founded in 2014 by Prof. Nico Karssemeijer and Prof. Sir Michael Brady. The CEO is Pieter Kroese. A $28 million Series C in July 2021 was led by Insight Partners, with Siemens Healthineers and Oost NL among existing investors. In April 2026 it raised EUR 13.6 million, EUR 11.9 million in equity from Insight Partners, Siemens Healthineers and others plus EUR 1.7 million in grants. Total raised is $47 million per Tracxn and $49 million per CB Insights.
Is it FDA cleared?
Yes. The 510(k) list under Screenpoint Medical B.V. runs from K181704 in November 2018 through K192287 (December 2019), K193229 (March 2020), K210404 (June 2021), K221347 (August 2022), K241831 (November 2024) and K260898 (August 14, 2026, Transpara 2.1.0). Transpara Density sits separately at K232096 from December 2023. ScreenPoint states it is FDA cleared and CE marked for 2D and 3D mammography.
Is there a public price?
ScreenPoint offers a virtual demo and a contact form and publishes no price.
The verdict
Transpara has three Lancet-family papers from a randomized trial behind it and a US clearance history that stretches back to 2018. It fits a screening program or radiology group that reads mammograms and wants a detection and triage aid with trial data behind it. The strongest numbers come from a European double-reading setting, so a US group without double reading would be extending those results to a different workflow.
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 |
|---|---|---|---|
| Enterprise | — | — | No public price. Virtual demo and contact only. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA 510(k), CE Mark (vendor-stated) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
What the literature says
3 peer-reviewed studies indexed on PubMed evaluate ScreenPoint Transpara in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- 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.
- Gommers J, Hernström V, Josefsson V, et al.· Lancet· 2026
- Evidence indicates that artificial intelligence (AI) can improve mammography screening by increasing cancer detection and reducing screen reading workload, but its effect on interval cancers (primary breast cancers diagnosed between two screening rounds or within 2 years after the last scheduled screening that were not detected at screening) is unknown. We aimed to compare the interval cancer rate in AI-supported mammography screening with standard double reading without AI. In this Swedish…
- 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.
- Hernström V, Josefsson V, Sartor H, et al.· Lancet Digit Health· 2025
- Emerging evidence suggests that artificial intelligence (AI) can increase cancer detection in mammography screening while reducing screen-reading workload, but further understanding of the clinical impact is needed. In this randomised, controlled, parallel-group, non-inferiority, single-blinded, screening-accuracy study, done within the Swedish national screening programme, women recruited at four screening sites in southwest Sweden (Malmö, Lund, Landskrona, and Trelleborg) who were eligible…
- 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.
- Lång K, Josefsson V, Larsson AM, et al.· Lancet Oncol· 2023
- Retrospective studies have shown promising results using artificial intelligence (AI) to improve mammography screening accuracy and reduce screen-reading workload; however, to our knowledge, a randomised trial has not yet been conducted. We aimed to assess the clinical safety of an AI-supported screen-reading protocol compared with standard screen reading by radiologists following mammography. In this randomised, controlled, population-based trial, women aged 40-80 years eligible for…
Other radiology
See the full radiology ranking
Siemens Healthineers AI-Rad Companion
by Siemens Healthineers
AI-Rad Companion: Chest CT, Chest X-ray, Brain MR, Prostate MR and Organs RT (radiotherapy contouring) modules, delivered through teamplay.
No public price on the vendor page.|FDA 510(k) (multiple) / CE Mark (MDD/MDR. MDR status not verified)
GE HealthCare AI Suite
by GE HealthCare
Portfolio of separately cleared AI-enabled GE HealthCare devices and software, including AIR Recon DL, Sonic DL, Critical Care Suite, Caption AI and icobrain.
No public price. Products are sold with scanners or as scanner options, on enterprise quotes.|FDA 510(k) (multiple)
Aidoc
by Aidoc
Clinical AI platform (aiOS) with FDA-cleared triage, notification and quantification algorithms for radiology and neurovascular care.
Private offer only. No trial is stated.|FDA 510(k) (multiple) / EU MDR 2017/745
Viz.ai
by Viz.ai
Care coordination platform with FDA-cleared imaging AI for stroke, vascular and cardiac conditions.
No public price. Sold to health systems after a demo request.|FDA 510(k) (multiple) / FDA De Novo (ContaCT, Viz HCM)