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# iCAD Cancer Detection Software Cleared
- URL: https://www.fdaweb.com/icad-cancer-detection-software-cleared/
- Published: 2018-12-07T12:00:00.000Z
- Updated: 2026-09-15T00:49:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142991

FDA has cleared an iCAD Inc. 510(k) for its ProFound AI, a cancer detection software solution for digital breast tomosynthesis that relies on artificial intelligence (AI). The clearance is based on positive clinical results from a large reader study completed earlier this year. The research was performed with 24 radiologists who read 260 tomosynthesis cases both with and without iCAD’s ProFound AI solution. “The findings show impressive results including increased cancer detection rates, reduced false positive rates and patient recalls, and a significant decrease in interpretation times,” the company says.