ScreenPoint Medical

by ScreenPoint Medical  · Based in Netherlands → — We are the Breast AI Company. We are bringing AI to the fight against breast cancer with leading clinical evidence and the latest deep learning technology.
breast-imaging Oncology Radiology

Regulatory Status Disclosed

Overview

ScreenPoint Medical is a leading innovator in AI-driven solutions for breast cancer detection and diagnosis. Their flagship product, Transpara, is an enterprise-grade AI tool designed to assist radiologists in interpreting mammograms and digital breast tomosynthesis (DBT) images. By leveraging advanced deep learning algorithms, Transpara aims to improve the accuracy and efficiency of breast cancer screening programs.

Transpara integrates seamlessly into existing radiology workflows, working alongside radiologists to provide a ‘second read’ or to prioritize studies based on AI-identified suspicious areas. This can help reduce reading times, decrease recall rates, and potentially improve the early detection of breast cancer, ultimately benefiting patient outcomes.

The platform is built with a strong emphasis on clinical validation and regulatory compliance, holding multiple regulatory clearances globally. ScreenPoint Medical collaborates with leading healthcare providers and PACS vendors to ensure secure and effective deployment within diverse clinical environments, including integration with platforms like Microsoft for Healthcare.

Physicians evaluating Transpara will find a tool designed to augment their expertise, providing objective and consistent analysis of breast imaging studies. Its capabilities extend to both 2D mammography and 3D DBT, offering comprehensive support for modern breast imaging practices. The company offers demonstrations to showcase the tool’s capabilities and discuss integration possibilities.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered breast cancer detection
  • 2D mammography analysis
  • 3D digital breast tomosynthesis (DBT) analysis
  • Second-read assistance for radiologists
  • Prioritization of suspicious cases
  • Integration with PACS systems
  • Enterprise-grade deployment
  • Regulatory clearances (FDA, CE Mark, Health Canada, TGA)

Use Cases

  • Breast cancer screening programs
  • Radiologist workflow optimization
  • Improving early detection rates
  • Reducing recall rates
  • Standardizing mammography interpretation
  • Training and quality assurance in breast imaging

What Physicians Need to Know

Evidence Base
ScreenPoint Medical's Transpara boasts an industry-leading body of clinical evidence, with over 55 peer-reviewed publications as of late 2025, and dozens of studies presented at major radiology conferences. It is the only breast cancer detection AI solution validated by randomized controlled trials (RCTs), including the MASAI study in Sweden, the PRISM trial in the USA, and the AIMS trial in Norway. The MASAI trial demonstrated a 29% increase in cancer detection and a 44% reduction in screen-reading workload compared to standard double reading, without increasing false positives. Transpara's performance has been evaluated in over 50 peer-reviewed studies and numerous conference presentations, with all data publicly available.
Clinical Validation Studies
Transpara has been rigorously validated in several large-scale studies. The MASAI study, a randomized controlled trial involving over 100,000 women in Sweden, showed a 29% increase in cancer detection and a 44% reduction in workload. A Dutch study of over 40,000 FFDM exams found AI detection comparable to double human reading. In a US study, Transpara flagged 76% of 3D mammograms initially read as normal but later linked to interval breast cancer, and 90% of missed reading error cases. The PRISM trial, a $16 million randomized controlled trial in the US, is currently evaluating Transpara's impact on early breast cancer detection, mammography accuracy, and patient callbacks. The AIMS trial in Norway is also investigating Transpara's latest algorithm. Studies have also shown Transpara's cost-effectiveness, with potential savings of u20ac59,320 per 1,000 women screened and an increase of 10.8 quality-adjusted life years.
Alert Fatigue Management
Transpara aims to reduce radiologist workload and cognitive overload, which are significant contributors to burnout and potential alert fatigue in breast imaging. By categorizing exams into 'Low,' 'Intermediate,' and 'Elevated' risk, and leaving 'Low Risk' cases unmarked, Transpara allows for more efficient review of approximately 70% of screening studies. Low-risk studies boast a 99.97% negative predictive value, increasing confidence in expedited review. This approach helps radiologists focus on higher-risk cases, potentially mitigating the effects of alert fatigue by reducing the number of alerts for benign findings.
Override Rate Data
While specific override rate data for Transpara is not explicitly detailed, the system is designed to provide decision support and act as a 'second pair of eyes,' rather than replacing the physician's judgment. The concurrent use indication implies that users decide how to integrate Transpara into their reading process. The goal is to enhance detection and reduce workload, suggesting that the AI's findings are intended to be valuable and trusted, thereby potentially reducing the need for overrides due to irrelevant alerts.
Differential Diagnosis Support
Transpara Detection identifies soft-tissue lesions and calcifications, assigning a score to both regions and the exam as a whole, representing the likelihood of malignancies. It categorizes areas of suspicion using a 98-point scale and assigns an overall exam category (Elevated, Intermediate, or Low) based on the highest region risk. This risk stratification and highlighting of suspicious areas provide crucial information to support radiologists in their differential diagnosis process.
Guideline Update Frequency
ScreenPoint Medical is committed to continuously evolving its Breast AI with innovative new products and enhanced algorithms. The company consistently strives to build products grounded in real-world problems and substantiated by rigorous scientific scrutiny. This implies ongoing development and updates to ensure the AI aligns with the latest clinical understanding and guidelines. For example, Transpara 2.1 offers notable performance increases in sensitivity compared to previous versions.
Clinical Workflow Integration
Transpara is designed for seamless and adaptable integration into existing radiology workflows. It can be used before, during, or after visual interpretation of an exam. It is integrated with platforms like Aidoc's aiOSu2122, Microsoft's Precision Imaging Network, and Ferrum Health's Model Hub, providing a unified interface for AI results and streamlining deployment. The system supports screening and diagnostic evaluations for both 2D mammograms and tomosynthesis (3D mammograms). It also integrates with reporting systems like Ikonopedia, allowing radiologists to view AI-powered insights alongside patient records and prioritize urgent cases. Transpara can function as decision support, an independent second reader, or a tool to optimize workflow, including potentially replacing a second reader or acting as a third reader in double-reading environments.
Physician Tip

Leverage Transpara's risk stratification to prioritize your workload, focusing on 'Elevated' and 'Intermediate' risk cases. Trust the high negative predictive value (99.97%) of 'Low Risk' cases to expedite their review, thereby improving efficiency and reducing cognitive load. Integrate Transpara's findings, including region-based scores and overall exam scores, into your diagnostic process for a 'second pair of eyes' to enhance confidence and detection. Utilize the temporal comparison feature to track findings across prior mammograms for more effective longitudinal comparisons. Remember that Transpara is a decision support tool, and your clinical judgment remains central to all patient management decisions.

Transpara is designed for broad compatibility and integrates seamlessly with various clinical ecosystems. It is available through platforms like Aidoc's aiOSu2122, Microsoft's Precision Imaging Network, and Ferrum Health's Model Hub, simplifying deployment and providing a unified interface for AI results. It also integrates with reporting systems such as Ikonopedia. The solution is vendor-agnostic, working with any acquisition gantry and readable in any preferred reading environment, ensuring flexibility within existing infrastructure.

Details

Category Clinical Decision Support & Reference, Oncology AI, Radiology & Imaging AI
Pricing Unknown — unknown
DeploymentCloud-enabled access through Precision Imaging Network (Microsoft for Healthcare), integrates into PACS and reading workflows via medical-imaging (DICOM) pipelines, on-premise installations.
API Available Yes
Target SizeHospitals, clinics, and breast screening programs.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Cleared AI-estimated

Transpara is FDA-cleared (K241831 and K232096) and CE (0344) certified for 2D and 3D mammography. The latest version, Transpara 2.1, is compatible with breast density options (BIRADS and volumetric) and temporal comparison, allowing analysis of suspicious areas against up to three prior exams over six years. Transpara is intended for use as a concurrent reading aid for physicians interpreting screening FFDM and DBT exams, to identify regions suspicious for breast cancer and assess their likelihood of malignancy.

GDPR Yes AI-estimated
Integrations
EHR Not specified
Specialties Breast Imaging, Oncology, Radiology

Social Proof

CustomersOver 30 countries and 13 million mammograms processed. Over 200 healthcare facilities in more than 25 countries. Selected by 40% of the 2025 US News and World Report's Top 20 Best Hospitals Honor Roll recipients.
Notable
unknown

What the Web Says

ScreenPoint Medical is a Dutch company specializing in AI-powered software for medical image analysis, primarily focusing on breast cancer detection with its flagship product, Transpara. The software is FDA-cleared and CE-marked and aims to assist radiologists in reading mammograms, improving detection rates, and reducing workload. Numerous studies and physician testimonials highlight its effectiveness in increasing cancer detection and enhancing workflow efficiency.

Overall: Positive

Strengths

  • Increases cancer detection rates, with studies showing up to a 29% increase without increasing false positives.
  • Reduces radiologist workload and reading time significantly, by as much as 44% in some studies, by prioritizing low-risk cases for expedited review.
  • Acts as a 'second pair of eyes' for radiologists, improving confidence and consistency in identifying subtle abnormalities.
  • Supported by a large body of clinical evidence, with over 55 peer-reviewed publications.
  • Integrates prior imaging data to boost performance and improve clinical workflows.
  • Effective across diverse patient populations, regardless of ethnicity, age, BMI, and breast density.

Limitations

  • Some initial concerns about potential overdiagnosis with higher cancer detection rates, although subtype analysis in studies has been favorable.
  • Radiologists may still need strategies to manage patient recall associated with intermediate-risk cases identified by the AI.
  • Limited independent user reviews available on platforms like G2 and Capterra specifically for ScreenPoint Medical, making it difficult to gauge broader user sentiment outside of published studies and company-provided testimonials.
  • The technology requires FDA review and approval for significant algorithm or functional updates.
  • Some radiologists are naturally cynical about new technologies claiming to revolutionize the field and require clear, tangible value.

Based on reviews from: Vertex AI Search, The Lancet Digital Health, AuntMinnie.com, Indeed.com, Reddit, G2.com, Capterra.com, YouTube

Last updated: 2026-08-06

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Press & Coverage

ScreenPoint Medical
ScreenPoint Medical Secures $16M to Lead the Next Phase of AI in Breast Cancer Care
ScreenPoint Medical announced securing $16 million in new funding from existing investors Insight Partners and Siemens Healthineers, along with research grants, to advance its AI solutions for breast cancer detection and risk assessment.
2026-04
ScreenPoint Medical
The Lancet publishes final results from the first randomized controlled trial in Breast AI
The final results from the MASAI randomized controlled trial, published in The Lancet, demonstrated that ScreenPoint Medical's Transpara-assisted workflow increased cancer detection by 29% and reduced radiologist workload by 44%.
2026-01
PR Newswire
ScreenPoint Medical and Ferrum Health partner to offer Transpara Breast AI through Ferrum's AI Governance Suite
ScreenPoint Medical partnered with Ferrum Health to make its Transpara Breast AI Suite available on Ferrum Health's Model Hub, aiming to provide health systems with a governed enterprise intelligence program for AI deployment, management, and measurement.
2026-01
PR Newswire
ScreenPoint Medical Enables Transparau00ae Breast AI within Precision Imaging Network, part of Microsoft for Healthcare
ScreenPoint Medical announced a commercial agreement to make its Transparau00ae breast-imaging AI portfolio available through Precision Imaging Network, part of Microsoft for Healthcare, enhancing access to breast AI tools for healthcare providers.
2025-12
PMC (PubMed Central)
Performance of an Artificial Intelligence Support System on Screening Mammography Cases Proceeding to Stereotactic Biopsy
This retrospective study evaluated the standalone performance of Transpara 1.7.1 (ScreenPoint Medical) in screening mammography cases proceeding to stereotactic biopsy, using histopathological results as ground truth.
2025-12
ScreenPoint Medical
ScreenPoint Medical highlights Transpara regulatory clearances
ScreenPoint Medical has achieved regulatory clearance for its algorithms in 40 countries, including FDA clearance and CE certification, allowing Transpara Detection to be used as decision support, an independent second reader, or a workflow optimization tool.
2025-10
ScreenPoint Medical
Transparau00ae Breast AI Selected for $16M PRISM Randomized Controlled Trial in USA
ScreenPoint Medical's Transparau00ae breast imaging AI solution was selected for the PRISM Trial, a $16 million randomized controlled trial in the United States funded by PCORI, to rigorously evaluate AI's role in breast cancer screening.
2025-09
Imaging Technology News
ScreenPoint Medical Acquires Biomediq A/S to Expand Breast Cancer Risk Assessment Capabilities
ScreenPoint Medical acquired Biomediq A/S to integrate its breast cancer risk analysis technology, which uses automatic, computer-based analysis of 2D and 3D mammograms, into ScreenPoint's Transpara Breast AI.
2025-01

Videos

Product demos, reviews, and walkthroughs for ScreenPoint Medical.

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Frequently Asked Questions

ScreenPoint Medical's Transpara AI is designed to be used concurrently by physicians interpreting 2D and 3D mammography exams. It functions as a decision support tool, helping radiologists identify suspicious regions, categorize areas of suspicion with a 98-point scale, and assign an Exam Category (Elevated, Intermediate, or Low) based on the highest Region Risk. This helps radiologists read exams faster and with more confidence, potentially increasing cancer detection and reducing workload.
Transpara has received FDA clearance (K241831 and K232096) and CE (0344) certification, and its algorithms are cleared in 40 countries globally. It is supported by over 50 peer-reviewed studies and has been deployed on a national and global scale, with large-scale studies from Denmark, Norway, and Spain attesting to its real-world impact. The MASAI randomized controlled trial, the first RCT in this field, demonstrated that Transpara Detection improves cancer detection by 29% while reducing reading workload by 44%.
Transpara is intended as an adjunct tool and not a replacement for a physician's own review of a mammogram; patient management decisions should not be made solely based on its analysis. While it aims to improve workflow and confidence, physicians should be aware that discussions of autonomous or 'rule-out' applications are currently investigational and not FDA-cleared or covered by the current CE certificate.
While the specific comparison data to all alternatives is not provided, ScreenPoint Medical asserts that Transpara has more peer-reviewed publications than any other breast AI vendor. It's designed to be vendor-agnostic and compatible with various acquisition gantries and reading environments. Other AI solutions for breast imaging exist, and partnerships, such as with Aidoc and Densitas, aim to integrate Transpara into broader AI platforms for a more comprehensive solution.
Specific pricing details for Transpara are not publicly available in the provided information. However, ScreenPoint Medical emphasizes seamless integration into existing clinical workflows and PACS systems. They work with IT teams to ensure smooth deployment and offer cloud-enabled access through platforms like Microsoft's Precision Imaging Network to simplify integration and scalability.
ScreenPoint Medical states that the security of their systems and the safety of patient data are paramount, with their security program aligned with ISO/IEC 27001 standards. They are committed to complying with European Data Protection Laws regarding information transferred outside the EEA and have a policy of limited access to personal data within their organization.
Yes, Transpara is cleared and marked for use with both 2D Full-Field Digital Mammography (FFDM) and 3D Digital Breast Tomosynthesis (DBT). It is designed to assist radiologists in interpreting both types of exams, providing decision support and enhancing workflow regardless of the acquisition type.

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Suggest an Edit → | Last Verified: 2026-08-05 | First Added: 2026-08-05
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