RAD Sherpa Receives FDA Clearance for AI Mammography Solution
By RAD Sherpa Communications
RAD Sherpa is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for our AI-powered mammography analysis solution. This regulatory milestone enables broader adoption of our technology in clinical practice across the United States.
About the Solution
RAD Sherpa's mammography AI is designed to assist radiologists in the detection and characterization of breast lesions. The system analyzes digital mammography images and provides:
- Automated detection of suspicious regions of interest
- Density classification according to BI-RADS categories
- Risk scoring to help prioritize worklist management
- Measurement tools for lesion characterization
Clinical Performance
In clinical studies submitted to the FDA, the mammography AI demonstrated:
- Sensitivity improvement of 8% when used as a second reader
- Reduction in false-positive callbacks by 12%
- Average reading time reduction of 25%
Statement from Leadership
"FDA clearance represents a significant milestone for RAD Sherpa and validates our commitment to developing AI solutions that meet the highest standards of safety and efficacy," said Dr. Pradeep Albert, Founder and CMO. "We believe this technology will help radiologists detect breast cancer earlier while reducing unnecessary patient callbacks."
Market Availability
The FDA-cleared mammography solution is now available for deployment in U.S. healthcare facilities. The system integrates seamlessly with existing PACS infrastructure and supports both 2D and 3D (tomosynthesis) mammography formats.
For more information about implementing RAD Sherpa's mammography AI in your practice, please contact our team.