Research & Regulatory

Built on evidence.

Peer-reviewed publications, clinical studies and a transparent regulatory pathway. This page tracks our progress toward CE marking (EU MDR, Class IIa) and FDA 510(k) clearance.

Publications Clinical studies Certifications

Publications

01 - Peer review

Conference2025

Longitudinal thermal pattern tracking in at-home screening

Placeholder - link each publication with DOI, authors and PDF.

MammoCheck Research Team

Clinical studies

02 - Validation

● OngoingCyprus

Clinical validation study with hospital partners

Sensitivity / specificity evaluation against standard-of-care screening.

PlannedMulti-site2026

Multi-site usability study (IEC 62366)

Human factors validation across target user groups.

Certifications & compliance

03 - Regulatory

In progress

ISO 13485 - Quality Management System

In progress

CE marking - EU MDR, Class IIa

Pathway defined

FDA 510(k) premarket notification

MammoCheck is an investigational device under development. Statuses on this page are updated as our regulatory work progresses - see also the full regulatory statement.