Zebra Medical Gets 510(k) Clearance for Mammography Tool

The FDA has granted Zebra Medical Vision 510(k) clearance for HealthMammo, an artificial intelligence-based tool that helps radiologists identify breast lesions on mammograms.

HealthMammo features software that automatically looks for “suspicious” mammograms and then sends them to the company’s imaging analytics platform to be assessed for cancerous lesions.

The product has already received a CE mark in Europe.