Vara has secured a European CE mark for an autonomous, artificial intelligence (AI)-powered breast cancer screening triage tool – marking the first time a device of this nature has secured an authorisation globally.

Designated as a Class IIb medical device under the EU’s medical device regulation (MDR), Vara’s designed its newly CE-marked autonomous triage tool to facilitate organised population screening. This means the technology can identify and stratify images based on if the breast is considered normal or needs further assessment by a radiologist.

To ensure autonomous triage is safe for use in healthcare, Vara created a specific safety system suitable for the job, which the company says played a foundational role in its CE certification. Dubbed ATMON, this technology allows for the real-time supervision of the autonomous AI to ensure accuracy, and is based on seven years of continuous, real-world monitoring.