The US Food and Drug Administration (FDA) has cleared a growing number of AI systems for breast imaging. These products must demonstrate safety and effectiveness through structured regulatory review before they can be marketed.
Cleared systems cover the main modalities: mammography (2D and 3D/tomosynthesis), ultrasound and MRI. Each clearance defines its intended use — flagging suspicious findings, prioritising cases or measuring lesions — and its performance data are public.
What FDA clearance means
- Independent review of safety and effectiveness
- Publicly available performance data
- A clearly defined intended use
- Continued monitoring of real-world performance
Approvals vary by country. Always check with your centre whether AI is used in your region and what evidence it rests on.