Startup Voucher 2025

Operation, activities and results

A public reporting view of BreastScreening-AI's human-centred clinical AI development, validation activities and supporting research.

Updated 13 June 2026 Preliminary clinical evidence Evidence progression: TRL 5 to TRL 6

Clinical decision support designed around radiologists

BreastScreening-AI develops and validates artificial intelligence tools that support the interpretation of breast imaging and clinical decision-making without replacing professional judgement. The operation combines multimodal imaging, human-computer interaction, clinical workflow integration and responsible AI evaluation.

Objectives

  • Improve the consistency and efficiency of breast imaging assessment.
  • Evaluate AI assistance in realistic clinical workflows with healthcare professionals.
  • Reduce avoidable diagnostic errors while preserving clinician control and accountability.
  • Prepare the technology, evidence and governance required for further clinical validation.

Progression from TRL 5 toward TRL 6

The Hospital da Luz work provided evidence of integration and usability testing in a relevant clinical environment. This supports a reported evolution from TRL 5 to TRL 6, while not constituting formal TRL certification or clinical deployment approval.

TRL 5

Validated prototype

Core components and AI-assisted workflows evaluated in representative settings.

TRL 6

Relevant-environment demonstration

Integration through Siemens syngo.via Frontier/OpenApps and usability activities with physicians.

Next

Broader validation

Larger prospective studies, consolidated CHTMAD outcomes and formal regulatory evidence.

TRL 6 is an evidence-based project interpretation, not an external certification.

Hospital da Luz exploratory pilot

The pilot involved seven physicians and assessed workflow integration, usability and decision support. Results are preliminary, use a small sample and should not be interpreted as clinical efficacy claims.

+11.82 percentage points

Exploratory improvement in triage-level decision accuracy.

81.82% decision stability

Decisions that remained unchanged with AI assistance.

p = 0.0036 exploratory analysis

Statistical result for the complementary triage analysis.

7 physicians

Participants in integration and usability activities.

Where the pilot showed measurable progress

The clearest observed effect was a +11.82 percentage-point improvement in the complementary triage-level analysis, supported by the exploratory statistical result of p = 0.0036.

BI-RADS remained the primary clinical reference throughout the pilot. The triage analysis provides an additional view of decision support and is not intended to replace BI-RADS or clinical judgement.

Approximate subset
11 patients
Image volume
23 images
Paired observations
110
Environment
Siemens syngo.via Frontier/OpenApps
Accessible data table comparing previous research and current pilot evidence.
Evidence periodIndicatorReported valueStatus
Previous, 2022False positives27% decreasePeer-reviewed research
Previous, 2022False negatives4% decreasePeer-reviewed research
Previous, 2022Positive expectations and satisfaction91% of cliniciansPeer-reviewed research
Current, 2026Triage-level decision accuracy change+11.82 percentage pointsExploratory pilot
Current, 2026Decision stability81.82%Descriptive pilot result
Current, 2026Clinical classification frameworkBI-RADS retainedPrimary clinical reference

CHTMAD / ULSTMAD research activities

CHTMAD activities investigated clinical reporting, documentation and human-machine-readable report structures using anonymised cases under an ethics-approved research protocol.

Current reporting status

Three fieldwork periods are documented: 17-21 November 2025, 5-9 January 2026 and 26-30 January 2026.

The available evidence supports reporting the activities and methodology. No consolidated quantitative outcome data was reported yet, so no CHTMAD timeline is published here.

Results reported in peer-reviewed research

These figures provide research context only. They come from a different study design and sample and must not be combined statistically with the Hospital da Luz pilot.

Artificial Intelligence in Medicine, 2022

BreastScreening-AI: Evaluating Medical Intelligent Agents for Human-AI Interactions

A real-world case study compared clinician-only and clinician-AI scenarios with 45 clinicians from nine institutions.

  • 27% decrease in false positives.
  • 4% decrease in false negatives.
  • 91% of clinicians reported positive expectations and perceptive satisfaction.
  • Time-to-diagnose decreased by three minutes per patient.
Read the publication
Published indicators from the 2022 peer-reviewed study.
Published indicatorReported result
False positives27% decrease
False negatives4% decrease
Positive expectations and satisfaction91% of clinicians
Time-to-diagnose3 minutes less per patient

Contributors to operation readiness

External organisations supported distinct technical, funding, legal, regulatory and intellectual-property workstreams.

SNAP

Proposal development, EIC project management and Grant Agreement Preparation support.

Leyton

Startup Voucher and PRR technical reporting, cost-eligibility and communication compliance support.

SAVEAS

Intellectual-property consultancy, including Freedom-to-Operate and term-sheet work.

KGSA

Our legal provider, supporting the company with corporate, contractual and legal matters.

Complear

Regulatory and independent-validation discussions for medical AI readiness.

AAVANZ

Supported the preparation of our EIC Pathfinder and Horizon Europe proposals.

Transparent by design

This page distinguishes confirmed pilot results, research activities and peer-reviewed evidence. Values are not pooled across studies. Clinical results remain preliminary until larger prospective validation and formal institutional review are completed.