AI-based breast triage tool receives approval without radiologist review

Berlin-based technology company Vara has achieved a world first under the European Union Medical Device Regulation with its autonomous breast triage tool, which can classify normal mammograms without the need for a radiologist's reading.

Autonomous Triage Approval

Berlin-based health technology firm Vara has announced that it has received CE certification for its autonomous breast triage product under the European Union Medical Device Regulation.

This approval allows normal mammograms to be classified by artificial intelligence without the need for a radiologist review.

Screenings in Europe

The company stated that this artificial intelligence approach is designed to alleviate the burden created by a shrinking radiologist workforce in programs where every mammogram is read twice.

The autonomous triage system is now available for use in screening programs across Europe.

Atmon Safety System

The safety and monitoring infrastructure behind the system, called Atmon, tracks hardware changes and daily performance in real time.

When signals go out of established bounds, the facility can be reverted to full radiologist reading.

Real-World Data

It was stated that the certification process was based on real-world performance, and research published in the journal Nature Medicine showed that Vara's tools could increase breast cancer detection.

The research drew attention as a large-scale study covering approximately 462,000 women across Germany.