MammoCheck lands €500K grant to chase FDA and CE approval for AI breast screening
What's the deal? MammoCheckDealroom has a profile for this one. Try Dealroom →, a Cypriot medical technology spin-out of Frederick UniversityDealroom has a profile for this one. Try Dealroom →, has secured €500,000 (≈$575,369) in grant funding from the Research and Innovation FoundationDealroom has a profile for this one. Try Dealroom →'s SEED Program. The money will fund clinical trials, quality management, and regulatory work toward US FDA 510(k) clearance and European CE marking.
What's the endgame? MammoCheck is building a Software as a Medical Device platform that combines a mobile app, thermal imaging, and a proprietary AI algorithm to support early breast cancer detection. Founded in 2024, it is designed to complement — not replace — mammography and ultrasound, and is intended for clinics and guided home use.
Why now? The startup is running a clinical trial across hospital centres in Cyprus, approved by the Cyprus National Bioethics Committee. The grant will help complete that trial, advance its ISO 13485 quality management system, and prepare technical documentation for the FDA and EU Medical Device Regulation pathways.
The company frames its market around a screening gap: global mammography access remains unequal, with coverage reported as low as 1.7% in some regions, leaving many women under 45 outside national programmes.
What could go wrong? Regulatory approval is far from guaranteed, and the funding is tied to milestones the company has yet to complete. MammoCheck is also running an open private investment round to fund commercial deployment, meaning the grant alone will not carry it to market.
The SEED Program, co-funded by the European Union and the Republic of Cyprus under the "THALIA 2021-2027" Cohesion Policy Program, backs Cypriot startups building internationally competitive products.
"Securing €500,000 in non-dilutive competitive funding represents a strong vote of confidence in our vision, team, and mission," said Alexandra Dimitriadou, co-founder and chief executive officer.
The signal: At €500,000, this is a modest early-stage grant — sitting in roughly the 45th percentile by amount — but it reflects a broader push to build regulated medical AI out of European academic research. For MammoCheck, non-dilutive capital buys time to clear the regulatory bar before commercial fundraising takes over.
Read more: Fast Forward
Image credit: Generated with Gemini
