ScreenPoint Medical B.V. - Global Leader in AI-Powered Breast Cancer Detection

📢 Key Milestones (2024–2026):
   In April 2026, ScreenPoINT Medical secured $16 million in new funding ($14M from existing investors Insight Partners and Siemens Healthineers, plus $2M in non-dilutive research grants) to fuel global expansion and personalized breast cancer care. In January 2026, the landmark MASAI randomized controlled trial final results were published in The Lancet, demonstrating that Transpara improves cancer detection by 29% while reducing radiologist workload by 44%. In June 2024, the FDA cleared Transpara 2.1.0 (K241831) with breakthrough capabilities including temporal comparison across up to 3 prior exams over 6 years and breast density assessment (BIRADS and volumetric).

Company Profile (Updated April 2026)

ScreenPoint Medical B.V. is a privately held artificial intelligence company headquartered in Nijmegen, The Netherlands. Founded in 2014 as a spin-off from Radboud University Medical Center by Professor Nico Karssemeijer and Professor Sir Michael Brady, the company develops cutting-edge mACHine learning solutions to improve early detection and diagnosis of breast cancer. ScreenPoint Medical translates advanced deep learning research into clinical tools accessible to radiologists, with the mission of reducing the global death toll from breast cancer through earlier detection.

The company's flagship product, Transpara® Breast AI, is the most clinically validated breast AI solution on the market, supported by over 50 peer-reviewed publications and multiple randomized controlled trials. Transpara is deployed in 30+ countries across hundreds of leADINg healthcare systems, screening programs, universities, and imaging groups, and has processed over 12 million mammograms to date.

Development History:

- 2014: Founded as a spin-off from Radboud University Medical Center, Nijmegen, by Professor Nico Karssemeijer (physicist and computer-aided diagnosis pioneer) and Professor Sir Michael Brady (Oxford University)

- 2018.11: Received first FDA 510(k) clearance (K183023) for Transpara 1.0 for 2D full-field digital mammography (FFDM), becoming the first AI application for breast cancer detection in screening mammograms to gain FDA approval

- 2020.01: FDA cleared Transpara 1.6.0 for 3D digital breast tomosynthesis (DBT) (K192858), making it the first breast AI solution cleared for both 2D and 3D mammography in the USA

- 2021.07: Raised $28 million Series C led by Insight Partners, with participation from Siemens Healthineers, Oost NL, and University Radiology Group (URG)

- 2021.11: Formed strategic partnership with Aidoc to integrate Transpara into Aidoc's AI platform; established new supervisory board including Dr. Rachel Brem and Allyson White (Insight Partners)

- 2022: Surpassed 4 million mammograms analyzed globally

- 2023.05: Reached 4 million mammograms analyzed milestone at Denmark's Capital Region screening program, the heaviest global user averaging ~75,000 mammograms annually

- 2024.03: Johns Hopkins Kimmel Cancer Center deployed Transpara across 7 locations after competitive evaluation, joining over 50 sites in the US Northeast

- 2024.04: Leadership transition: Pieter Kroese appointed CEO (previously COO for 5+ years); Mark Koeniguer stepped down after serving as CEO since 2022

- 2024.06: FDA cleared Transpara 2.1.0 (K241831) with advanced temporal comparison and breast density assessment capabilities; standalone performance demonstrated in top 10% of radiologists

- 2025.09: Transpara selected for the $16M PRISM randomized controlled trial in the United States to study AI-supported breast cancer screening

- 2026.01: Final results of the MASAI RCT published in The Lancet, confirming Transpara delivers "consistently favourAble outcomes compared with standard double reading"

- 2026.03: Prospective research on autonomous AI triage published in Nature Medicine, showing Transpara can safely reduce screening workload by up to 63.6%

- 2026.04: Secured $16 million in new funding ($14M from Insight Partners and Siemens Healthineers; $2M non-dilutive research grants) for global scaling and product innovation

Core Mission: To build AI-powered technology for every step of the breast imaging continuum, improving consistency, reducing uncertainty, enhancing patient experience, and translating opportunity into tangible outcomes for clinicians and women worldwide.

Core Product: Transpara® Breast AI

Transpara Detection

AI-Powered Lesion Detection: Deep learning algorithms automatically identify suspicious soft-tissue lesions (masses, architectural distortions, asymmetries) and calcifications in mammograms and tomosynthesis images

- Region Scores: Per-finding suspicion scores on a 1-100 scale

- Exam Score: Overall cancer likelihood categorized on a 1-10 scale or as Low / Intermediate / Elevated risk

- Interactive Decision Support: Real-time concurrent use during radiologist reading to improve detection and characterization

Transpara 2.1 Advanced Features

- Temporal Comparison: Analyzes suspicious areas against up to 3 prior exams over 6 years, a first-of-its-kind capability in the breast AI market

- Breast Density Assessment: Automated BIRADS and volumetric breast density classification

- Workflow Optimization: CE-marked for use as decision support, independent second reader, partial replacement of second reader, or third reader in double-reading programs

Clinical Evidence

- MASAI Trial (Sweden): First and only RCT in breast AI; improved cancer detection by 29% and reduced reading workload by 44% (The Lancet, January 2026)

- Real-World Adoption: ~65% of Danish screening programs, ~40% of Swedish regions, and one-third of Spain's screening population actively implement Transpara

- Interval Cancer Detection: Research shows up to 45% of interval cancers can be found earlier using Transpara

- Risk Prediction: Image-based breast cancer risk algorithm outperformed Mirai, iCAD, and Google at 5-year risk prediction; within the highest 14% of risk scores, predicted 41.8% of all future cancers and 50.3% of interval cancers (npj Digital Medicine)

Regulatory Clearances

Transpara holds regulatory clearance in 40 countries worldwide:

- United States (FDA): 510(k) cleared for 2D and 3D mammography — K241831 (Transpara 2.1.0), K232096, K192858 (3D/DBT), K183023 (2D/FFDM)

- European Union (CE): CE (0344) certified under MDR for 2D and 3D mammography; approved for decision support, independent second reader, partial replacement of second reader, or third reader

- Other Markets: Health Canada licensed and approved by national regulators across Asia-Pacific, Latin America, and the Middle East

Financial Performance & Funding

Funding History

- Seed / Early Rounds: Backed by founders, Siemens Healthineers, and Oost NL (Netherlands regional development agency)

- Series C (July 2021): $28 million led by Insight Partners; participation from Siemens Healthineers, Oost NL, and University Radiology Group (URG)

- Strategic Round (April 2026): $16 million ($14M equity from Insight Partners and Siemens Healthineers + $2M non-dilutive research grants)

- Total Funding: Over $44 million

Investors

- Insight Partners: Global venture capital and private equity firm; lead investor in Series C and 2026 round

- Siemens Healthineers: Strategic corporate investor and commercial partner

- University Radiology Group (URG): One of the largest US subspecialty radiology providers; clinical and investment partner

- Oost NL: Dutch regional development agency

Company Overview

Corporate Information

Legal Name: ScreenPoint Medical B.V.

Founded: 2014

Headquarters: Mercator II, 7th Floor, Toernooiveld 300, 6525 EC Nijmegen, The Netherlands

Company Type: Privately held (B.V. — Besloten Vennootschap)

Industry: Medical AI / Healthcare Technology / Radiology Software

Employees: 51–200

Core Product: Transpara® Breast AI

Website: www.screenpoint-medical.com

Leadership Team (2024–2026)

CEO: Pieter Kroese (appointed April 25, 2024; previously COO for 5+ years)

Founder & Chief Scientific Officer: Professor Nico Karssemeijer, PhD (physicist; former CEO for first 8 years; professor emeritus at Radboud University)

Co-Founder & Chairman of the Board: Professor Sir Michael Brady (Oxford University)

Chief Technology Officer: Pieter Kroese (former role; transitioned to CEO)

VP of QA/RA: Robin Barwegen

VP of Customer Success (EMEA + APAC + Latam): Esther Smits

VP of Engineering: Murat Onder

VP of Marketing: Sanmitra Deo Iwanski

VP of Sales (U.S.): Nicki Bryan

Chief Commercial Officer: Ad-Jan Bos

Board of Directors

- Sir Michael Brady: Chairman of the Board, Co-Founder

- Dr. Rachel Brem, MD: Internationally recognized breast radiologist; Transpara user and board member

- Allyson White: Principal at Insight Partners

Global Market Presence & Key Customers

Major Deployments

- Denmark: Capital Region screening program — heaviest global user, averaging ~75,000 mammograms annually; ~65% of Danish screening programs use Transpara

- Sweden: ~40% of Swedish regions implement Transpara; MASAI trial national deployment

- Spain: One-third of Spain's screening population covered

- United States: Johns Hopkins Kimmel Cancer Center (7 locations), University Radiology Group (URG), and 50+ sites across NY, NJ, PA, MD, VA, and DC

- Norway: Breast Screen Norway national program

Commercial Partners

- Siemens Healthineers: Strategic investor and global distribution partner

- Aidoc: Integration of Transpara into Aidoc's enterprise AI platform

- Ferrum Health: Partnership to expand AI-powered breast imaging access (January 2026)

Key Competitors

- Kheiron Medical (UK): Mia® breast screening AI

- iCAD: ProFound AI® for breast imaging

- Lunit (South Korea): INSIGHT MMG

- Google Health / DeepMind: AI breast cancer research (non-commercial direct competitor)

Competitive Advantages

- Most Clinical Evidence: Largest number of independent peer-reviewed publications of any deep learning breast AI solution (50+ studies)

- First Mover: First AI application for breast cancer detection in screening mammograms to receive FDA clearance (2018)

- RCT Leadership: Only breast AI company with published randomized controlled trial results (MASAI in The Lancet)

- Global Scale: 12+ million mammograms processed across 30+ countries

- Workflow Flexibility: CE-marked for multiple reading configurations (second reader, third reader, partial replacement)

- Temporal Innovation: First and only breast AI with FDA-cleared 6-year temporal comparison across 3 priors

2026 Strategic Priorities

- Global Scaling: Leverage $16M funding to expand commercial presence in the US, Europe, and Asia-Pacific

- Personalized Care: Accelerate development of risk stratification and personalized screening interval solutions

- PRISM Trial: Support the US-based PRISM randomized controlled trial studying AI-supported breast cancer screening

- Product Innovation: Continue annual algorithm updates and expand the Breast AI Suite beyond detection to risk assessment and workflow optimization

- Integrated Solutions: Deepen partnerships with imaging OEMs and PACS vendors for seamless clinical integration

Contact Information

Global Headquarters

Address: Mercator II, 7th Floor, Toernooiveld 300, 6525 EC Nijmegen, The Netherlands

Phone: +31 24 303 0045 / +31 24 202 0020

Website: www.screenpoint-medical.com

US Operations

VP of Sales (USA): Nicki Bryan — nicki.bryan@screenpointmed.com — +1 412 208 5991

Europe & Rest of World: David Lee — david.lee@screenpointmed.com — +44 (0) 7470 299 318

Media Contact

Cameron D. Bowman — cameron.bowman@screenpointmed.com

Keywords: ScreenPoint Medical, Transpara, Breast AI, mammography, digital breast tomosynthesis, DBT, deep learning, artificial intelligence, breast cancer detection, early detection, FDA 510(k), CE mark, Nijmegen, Netherlands, Radboud University, Nico Karssemeijer, Michael Brady, Pieter Kroese, Insight Partners, Siemens Healthineers, MASAI trial, PRISM trial, screening, radiology, workflow optimization, Johns Hopkins, Denmark, Sweden, Spain, University Radiology Group, Aidoc, Ferrum Health