News Summary

• Vara announced the certification on Wednesday in a statement issued through Business Wire.
• The mark is a Class IIb CE certification under the EU Medical Device Regulation.
• Vara credits the certification less to the model than to the safety layer wrapped around it.
• It calls that layer ATMON, for Autonomous-Triage Monitoring.
• The company says ATMON sets and monitors each site’s operating point, then tracks changes in mammography hardware, system health and daily performance signals.
• When those numbers move outside defined limits, it reverts the site to full radiologist reading.