Kaerro is being developed as a decision‑support and triage tool for mammography. We do not provide diagnostic outputs and do not replace the judgment of radiologists or technologists.
The Mammography Quality Standards Act (MQSA) and many state laws require that patients be notified if their breast tissue is dense (typically BI‑RADS categories C or D). Kaerro’s models include density estimation to assist clinicians in identifying these cases and ensuring appropriate notification. Our overlays and summaries are designed to streamline workflow and support compliance with these regulations.
Kaerro is not yet cleared by the U.S. Food and Drug Administration. We are aligning our development with FDA guidance for software as a medical device (SaMD), including IEC 62304 (software life‑cycle), ISO 14971 (risk management) and 21 CFR 892. Our quality management system includes design history, risk analysis and post‑market surveillance planning.
When ready, we anticipate pursuing a 510(k) submission for our dense‑breast triage module. Pilot evidence and usability studies will inform this process. To access our design documentation or collaborate on validation, please contact us directly.
This page is for informational purposes only. Nothing herein should be construed as a claim of regulatory clearance, diagnostic capability or clinical performance.