EU-CAD · Project

Accurate Heart Blood Flow Scanning Made Routine for Hospitals Worldwide

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Imagine your doctor needs to check if enough blood is reaching your heart. Right now, most hospitals use a scanning method (SPECT) that's like looking through a foggy window — it gives an okay picture but misses a lot. There's a much better method using a special radioactive water tracer in PET scanners, backed by over 450 scientific studies, but it's been too complicated and expensive for everyday use. MedTrace built a combined hardware-and-software package that finally makes this gold-standard scan practical and affordable, so hospitals can swap out their blurry test for a sharp, reliable one.

By the numbers

500,000+

PET scanners installed worldwide (2017), representing the addressable market

450+

peer-reviewed publications validating 15O-water as the gold standard cardiac tracer

EUR 2,500,000

EU contribution for clinical validation and CE approval

EU hospital sites selected for clinical validation

SME partner (MedTrace Pharma A/S, Denmark) — fully industry-led consortium

The business problem

What needed solving

Coronary artery disease is the leading cause of death globally, yet hospitals rely on SPECT imaging that delivers poor diagnostic accuracy and low patient throughput. The gold standard — 15O-water PET scanning — exists and is proven in over 450 studies, but has been impractical for routine clinical use due to the tracer's ultra-short half-life, complex image analysis, and lack of regulatory-approved equipment. Hospitals are stuck with inferior diagnostics because no one has packaged the better solution into something they can actually buy and use.

The solution

What was built

MedTrace built a combined hardware and analytical software solution (aQuant) that makes 15O-water PET cardiac imaging practical for routine hospital use. The project delivered validated code and infrastructure tested at selected European hospitals according to EU regulatory standards, with the goal of obtaining CE approval.

Audience

Who needs this

Hospital cardiology departments looking to upgrade from SPECT to PET-based cardiac imagingMedical device distributors seeking high-value diagnostic imaging products for the European marketRadiopharmaceutical companies wanting to expand into the cardiac PET tracer segmentHealth insurance companies evaluating cost-effective cardiac diagnostic pathwaysNational health systems planning cardiac imaging infrastructure modernization

Business applications

Who can put this to work

Hospital Networks & Cardiology Departments

enterprise

Target: Hospital groups or cardiology centers operating PET scanners

If you are a hospital network running cardiac imaging departments and struggling with low diagnostic accuracy from SPECT scans — this project developed a turnkey hardware-and-software solution (aQuant) that enables routine 15O-water PET scanning. With over 500,000 PET scanners installed worldwide, adoption requires no new scanner purchase — just adding MedTrace's equipment to existing infrastructure. The result is higher diagnostic accuracy, faster patient throughput, and lower per-scan costs.

Medical Device Distribution

mid-size

Target: Distributors of diagnostic imaging equipment in Europe

If you are a medical device distributor looking for high-margin cardiac imaging products — MedTrace's CE-track solution for 15O-water PET addresses a multi-billion-euro market opportunity. The system was validated at three EU hospital sites during the project period (2020–2022). As a distributor, you could offer hospitals a clear upgrade path from SPECT to quantitative PET without replacing their existing scanners.

Pharmaceutical & Radiopharmaceutical Manufacturing

any

Target: Companies producing PET tracers or radiopharmaceuticals

If you are a radiopharmaceutical company and want to expand your tracer portfolio — the EU-CAD project proved that 15O-water, despite its ultra-short half-life, can be made clinically practical with the right production and analysis tools. Partnering with or licensing from MedTrace could let you tap into the cardiac PET segment, supported by more than 450 peer-reviewed publications validating the tracer's superiority.

Frequently asked

Quick answers

What does this solution cost compared to current cardiac imaging?

The project objective states that 15O-water PET achieves unrivalled accuracy at a low cost compared to current SPECT practice. Specific pricing is not disclosed in the project data, but the value proposition centers on using existing PET scanner infrastructure (over 500,000 installed worldwide) rather than requiring new capital equipment.

Can this scale to large hospital networks?

Yes. The system was designed for routine clinical use, not just research labs. The aQuant software and supporting hardware were validated at three EU hospital sites. Since it works with existing PET scanners, scaling requires deploying the MedTrace add-on package — not installing new scanners.

What is the IP and licensing situation?

MedTrace Pharma A/S owns the technology as the sole consortium partner. The project pursued CE regulatory approval for the European market and planned a Phase III clinical trial for US FDA approval. Licensing or partnership inquiries should be directed to MedTrace in Denmark.

What regulatory approvals does this have?

The project aimed to obtain CE approval for the European market during its 2020–2022 period. A Phase III clinical trial was planned for US regulatory approval. Based on available project data, the CE approval process was part of the project scope but final status is not confirmed in the data.

How long before a hospital could deploy this?

The technology was at working prototype stage at project start and underwent clinical validation at three EU sites during the two-year project. For European hospitals, deployment timeline depends on CE marking status. US hospitals would need to wait for FDA clearance following the planned Phase III trial.

Does this integrate with our existing PET equipment?

Yes, that is a core design principle. The solution specifically targets the installed base of existing PET scanners. MedTrace's hardware and aQuant analytical software are designed as add-ons, not replacements. The deliverable on code and infrastructure validation focused on testing compatibility at multiple hospital sites.

Consortium

Who built it

This is a single-company project: MedTrace Pharma A/S, a Danish SME, is the sole partner with 100% industry composition. This is typical for SME Instrument Phase 2 funding, where a commercially-driven company receives EU support to bring a near-market product through validation and regulatory approval. The absence of university or research partners signals that the fundamental science is already settled (450+ publications) and the remaining work is engineering, clinical validation, and regulatory. For a business partner, this means you'd be dealing directly with the company that owns and develops the technology — no complex consortium politics or split IP.

How to reach the team

MedTrace Pharma A/S is a Danish SME — contact their business development team via medtrace.dk

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Next steps

Talk to the team behind this work.

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