Transpara

by ScreenPoint Medical B.V.  · Based in Netherlands → — Earlier detection and enhanced workflow in 2D and 3D mammography with Breast AI.
Obstetrics & Gynecology Radiology

Enterprise
Regulatory Status Disclosed

Overview

Transpara, developed by ScreenPoint Medical B.V., is an advanced Artificial Intelligence (AI) solution designed to assist radiologists in the early detection of breast cancer and to optimize their workflow when interpreting 2D Full-Field Digital Mammography (FFDM) and 3D Digital Breast Tomosynthesis (DBT) images. It acts as a ‘second pair of eyes,’ providing decision support by identifying regions suspicious for breast cancer and assigning risk scores to both specific areas and the overall exam. This AI-powered tool aims to improve diagnostic accuracy, increase radiologist confidence, and ultimately enhance patient outcomes through earlier intervention.

The system offers a suite of AI applications, including Transpara Detection, which categorizes exams into Elevated, Intermediate, and Low-risk categories, highlighting areas of suspicion. Notably, cases classified as Low Risk have a high negative predictive value (99.97%), allowing for expedited review and significant workload reduction. Transpara also features Transpara Density for consistent BI-RADS-like and volumetric breast density assessment, and Transpara Temporal Comparison, which analyzes current studies against up to three prior mammograms over a 6.5-year span to track changes over time, further increasing sensitivity and specificity.

Transpara is clinically validated with an extensive body of research, including multiple peer-reviewed studies and randomized controlled trials. It is designed for seamless integration into existing radiology workflows, compatible with various PACS systems, AI platforms, and imaging solutions. This adaptability ensures that radiologists can leverage AI insights within their established reading environments without disruption, supporting efficient, AI-enhanced breast cancer screening in both screening and diagnostic settings across diverse healthcare infrastructures.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered detection for 2D and 3D mammograms (FFDM and DBT)
  • Temporal Comparison (analyzes current study against up to 3 priors over 6 years)
  • Breast Density assessment (BI-RADS-like and volumetric)
  • Risk categorization (Elevated, Intermediate, Low)
  • Region-based and overall exam scores
  • Workflow optimization and workload reduction
  • Concurrent reading aid for radiologists
  • High negative predictive value for low-risk cases (99.97%)
  • Integration with PACS systems and AI platforms
  • DICOM Mammography CAD Structured Report output

Use Cases

  • Earlier breast cancer detection
  • Enhancing radiologist workflow and efficiency
  • Reducing radiologist workload
  • Improving diagnostic confidence in mammography interpretation
  • Triage of mammograms (prioritizing high-risk cases, expediting low-risk cases)
  • Breast cancer screening and diagnostic evaluations

What Physicians Need to Know

Evidence Base
Transpara boasts an industry-leading body of clinical evidence with over 55 peer-reviewed publications and dozens of studies presented at leading radiology conferences. It is FDA cleared and CE marked for both 2D and 3D mammography. The AI algorithm has been trained on over 1 million mammograms from diverse clinical sources globally, utilizing a large database of biopsy-proven examples of breast cancer, benign abnormalities, and normal tissue. Its performance has been evaluated in multiple large-scale, real-world screening populations across various institutions and countries.
Clinical Validation Studies
Transpara is the first and only Breast AI solution validated by a randomized controlled trial (RCT), the landmark MASAI study in Sweden. The MASAI trial demonstrated a 29% increase in cancer detection and a 44% reduction in screen-reading workload compared to standard double reading across over 100,000 women, without increasing false positives. It also resulted in a 12% reduction in interval cancers and 16% fewer invasive interval cancers. Studies at UCLA showed Transpara flagged 76% of 3D mammograms initially read as normal but later linked to interval breast cancer, and 90% of missed reading error cases, potentially reducing mammographically visible breast cancers by up to 30%. In a U.S. study, Transpara accurately identified nearly 50% of false negative breast cancers, predominantly in dense breasts. Ongoing RCTs, including the PRISM Trial in the USA and the AIMS trial in Norway, are further evaluating its efficacy.
Alert Fatigue Management
Transpara addresses alert fatigue by categorizing exams into three risk levels: Elevated, Intermediate, and Low. Critically, low-risk cases are unmarked for expedited review, boasting a 99.97% Negative Predictive Value (NPV). This allows radiologists to confidently and quickly review these cases, significantly reducing workload (e.g., up to 44% in the MASAI trial and up to 70% in some scenarios by eliminating double reading for low-risk studies). Unlike traditional CAD systems, Transpara provides 'up front information' for true decision support, flagging only areas of genuine concern.
Override Rate Data
While specific override rate data is not explicitly detailed, Transpara is designed as an adjunct tool to support radiologists, not replace their judgment. Clinicians retain the ability to review and override AI recommendations. The high NPV for low-risk cases (99.97%) suggests that overrides for these confidently negative cases would be minimal, contributing to workflow efficiency.
Differential Diagnosis Support
Transpara supports differential diagnosis by identifying soft-tissue lesions and calcifications, assigning a score to both regions and the overall exam to indicate the likelihood of malignancy. It categorizes exams by risk (Elevated, Intermediate, Low) and provides Region Risk marks to highlight suspicious areas. The tool also includes Transpara Density, which offers BI-RADS-like and volumetric breast density assessments for consistent analysis. A robust Temporal Comparison feature allows radiologists to analyze suspicious areas against up to three prior mammograms (from 9 months to 6.5 years prior), aiding in the detection of subtle changes over time.
Guideline Update Frequency
ScreenPoint Medical continuously trains Transpara with more data and aims to improve the algorithm and add new features on an annual basis. For example, Transpara 2.1 represents an updated algorithm based on additional training and insights.
Clinical Workflow Integration
Transpara is designed for seamless integration into existing radiology workflows, including through platforms like Aidoc's aiOSu2122 and Microsoft for Healthcare's Precision Imaging Network. It works concurrently with radiologists to streamline reviews, prioritize high-risk cases, and enhance cancer detection. The system's ability to confidently classify 70% or more of exams as low risk and unmarked allows for expedited review, significantly improving workflow efficiency and reducing reading time (e.g., 26% time savings in tomosynthesis studies). It can be used as decision support, an independent second reader, or to optimize workflow, including potentially replacing a second reader in double-reading environments.
Decision Audit Trail
While not explicitly termed 'Decision Audit Trail,' Transpara provides clear outputs such as Region Risk marks and an overall exam score, creating a record of the AI's assessment for each case. The integration with platforms like Ferrum Health's Model Hub allows healthcare systems to validate the algorithm against their local data and monitor outcomes and performance over time, implying a level of auditability and transparency in AI-assisted decisions.
Physician Tip

Leverage Transpara's risk categorization to prioritize your workload, confidently expediting the review of low-risk cases (NPV 99.97%) to focus more intensely on intermediate and elevated risk studies. Utilize the AI's Region Risk marks and overall exam scores as a 'second pair of eyes' to enhance detection and diagnostic confidence, especially for subtle findings. Integrate the temporal comparison feature to track changes over time, which is crucial for accurate diagnosis. Remember that Transpara is a decision support tool; your clinical expertise and final judgment remain paramount.

Transpara is designed for seamless integration into existing radiology workflows and PACS systems. It supports both 2D and 3D mammography from various manufacturers. The solution is compatible with enterprise AI platforms like Aidoc's aiOSu2122 and Microsoft for Healthcare's Precision Imaging Network, offering streamlined deployment, management, and a unified interface for AI results within your current clinical ecosystem. This facilitates scalable, secure, and governed AI adoption, allowing for local validation and ongoing performance monitoring.

Details

Category Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Enterprise — Enterprise custom pricing; contact vendor for details.
DeploymentOn premise
Mobile AppNone
API Available Yes
Data Export Yes
LanguagesEnglish
Training Yes
Target SizeSolo to large health systems
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Cleared AI-estimated — 510(k) K241831, K232096 (for Transpara 2.1, 2D and 3D mammography)
Integrations
EHR Not specified
Specialties Obstetrics & Gynecology, Radiology

Social Proof

CustomersHundreds of leading centers in 30+ countries; over 11 million mammograms analyzed
Notable
Johns HopkinsUCLAUniversity Diagnostic Medical Imaging (UDMI)Capital Region of DenmarkLund University (Sweden)Norwegian Cancer RegistryReina Sofia Hospital Cordoba (Spain)

Support & Reliability

Training Provided Yes

Ratings & Reviews

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Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

Applied Radiology
ScreenPoint Medical's Transpara Breast AI Suite Joins Ferrum Health's Model Hub to Support Scalable, Trusted AI Deployment
ScreenPoint Medical's Transpara Breast AI Suite, including Detection, Density, and Temporal Comparison tools, is now available on Ferrum Health's Model Hub to assist radiologists in early breast cancer detection and reduce workload. This partnership aims to integrate clinically validated AI technology with an enterprise-wide governance solution for scalable and trusted AI deployment in healthcare.
2026-01
ScreenPoint Medical
The Lancet publishes final results from the first randomized controlled trial in Breast AI
New research from the MASAI trial, published in The Lancet, highlights that Transpara Detection contributed to a 12% reduction in interval cancers and a 29% increase in cancer detection, while reducing screen-reading workload by 44%. This randomized controlled trial, involving over 105,000 women, demonstrates the significant impact of AI in mammography screening.
2026-01
AuntMinnie
ScreenPoint Medical raises $16M for breast AI expansion
ScreenPoint Medical has secured $16 million in funding from existing investors and research grants to advance product development and global expansion of its Transpara breast AI solutions. This announcement coincides with recent research milestones, including favorable outcomes from the MASAI trial and studies showing workload reduction.
2026-04
ScreenPoint Medical
Transparau00ae Breast AI Selected for $16M PRISM Randomized Controlled Trial in USA
ScreenPoint Medical's Transpara breast imaging AI solution has been chosen for the PRISM (Pragmatic Randomized Trial of Artificial Intelligence for Screening Mammography) Trial, a $16 million randomized controlled trial in the United States. This trial will rigorously evaluate the role of AI in breast cancer screening.
2025-09
BioSpace
Transpara Announces New FDA Clearance Designed to Improve Breast Cancer Detection at RSNA
ScreenPoint Medical showcased a new FDA clearance for Transpara 2.1 at RSNA 2024, featuring updated algorithms compatible with breast density options and temporal comparison capabilities. This advancement allows analysis of suspicious areas against up to three prior studies over six years, aiming to improve breast cancer detection.
2024-12
Imaging Technology News
Transpara Surpasses 5 Million Mammograms and 1 Million Tomosynthesis Studies Analyzed to Support Radiologists Reading Mammograms
ScreenPoint Medical announced that its Transpara breast AI has analyzed over 5 million mammograms, including more than 1 million 3D tomosynthesis exams, assisting radiologists in earlier cancer detection and reduced recall rates. The company highlighted these milestones at RSNA 2023.
2023-11
PR Newswire
ScreenPoint Medical: Transparau00ae Breast AI demonstrates value in real-world clinical usage.
ScreenPoint Medical announced that its Transpara breast AI has surpassed 4 million mammograms analyzed, demonstrating its value in real-world clinical usage. The company highlighted Transpara's FDA clearance and European regulatory approval for 2D and 3D mammography.
2023-05
AuntMinnie
Fairfax to incorporate ScreenPoint's Transpara in its imaging centers
Fairfax Radiology in Virginia has decided to integrate ScreenPoint Medical's Transpara breast artificial intelligence (AI) software into its imaging centers. The software is designed to help radiologists identify potential breast malignancies earlier.
2023-05

Videos

Product demos, reviews, and walkthroughs for Transpara.

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Frequently Asked Questions

Transpara integrates into existing radiology workflows, acting as a 'second pair of eyes' to assist radiologists in reading 2D and 3D mammograms. It provides an Exam Score to categorize risk, highlights suspicious areas as a Perception Aid, and offers Decision Support to help focus on critical regions, ultimately aiming to improve reading efficiency and confidence.
Clinical studies, including the MASAI randomized controlled trial, demonstrate that Transpara-supported screening can increase cancer detection by up to 29% and reduce radiologist workload by 44% without increasing false positives. It has shown a high negative predictive value for low-risk exams and can identify false-negative cancers, particularly in dense breasts.
Transpara is FDA-cleared in the United States and holds CE-marking in Europe, along with regulatory clearances in over 40 countries globally. These clearances permit its use as a decision support tool, an independent second reader, or a workflow optimization solution, ensuring adherence to national and international medical device standards.
While effective, some studies indicate Transpara may have a higher false-positive rate in certain high-risk patient subsets, and its performance can vary by lesion type, such as lower for asymmetry. It is not designed for synthetic, stereotactic, spot compressed, or other non-standard mammographic views, nor for images containing implants or pacemakers.
Key alternatives in AI-powered breast cancer screening include ProFound AI by iCAD and HealthMammo by Zebra Medical Vision. Comparative studies suggest that while both Transpara and ProFound AI demonstrate high performance, ProFound AI has sometimes shown a higher Area Under the Curve (AUC) for breast cancer detection, particularly in non-dense breasts.
Transpara is generally offered through annual subscription models, with licensing options that can include named or concurrent user licenses, or site/enterprise-wide agreements. Specific pricing details are typically not publicly disclosed and require direct consultation with ScreenPoint Medical or its partners.
Transpara is designed for seamless integration with existing PACS and mammography systems, supporting various acquisition gantries and reading environments. The latest versions also incorporate temporal comparison capabilities, allowing analysis of current studies against up to three prior exams over six years to aid in detecting subtle changes.

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More from ScreenPoint Medical B.V.

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ScreenPoint Medical offers Transpara, an AI-powered solution for breast cancer detection and diagnosis in mammography and digital breast tomosynthesis, designed to assist radiologists.
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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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