Last updated: June 2026.
MammoCheck is an investigational medical device currently under development and is not yet available for sale. It has not been cleared or approved by the FDA, and CE marking under the EU MDR is in progress. MammoCheck is intended as an adjunctive tool and does not replace clinical breast examinations, mammography, or professional medical advice. If you notice changes in your breast health, consult a healthcare professional.
Device status
MammoCheck is an investigational device under development. It is not available for sale and may not be placed on the market in any jurisdiction until the applicable conformity assessment and clearance procedures are complete.
European Union
MammoCheck is pursuing CE marking under the EU Medical Device Regulation (MDR 2017/745) as a Class IIa device. An ISO 13485 quality management system is being implemented as part of this pathway.
United States
MammoCheck is pursuing FDA 510(k) clearance. The device has not been cleared or approved by the U.S. Food and Drug Administration.
Intended use positioning
MammoCheck is designed as an adjunct to - not a replacement for - clinical screening such as mammography. It is intended to help users monitor, map and track changes in breast thermal patterns over time and to share reports with healthcare professionals. It does not provide a diagnosis.
Clinical evidence
Our clinical and usability studies, publications and certification progress are listed on the Research page and are updated as work progresses.
Questions
For regulatory enquiries, contact [email protected].