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# FDA Clears iCAD’s Latest Breast Density Software
- URL: https://www.fdaweb.com/fda-clears-icads-latest-breast-density-software/
- Published: 2018-08-08T12:00:00.000Z
- Updated: 2026-09-15T00:24:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142070

FDA has cleared an iCAD 510(k) for its latest artificial intelligence software solution — PowerLook Density Assessment Version 3.4\. The software is compatible with iCAD’s digital breast tomosynthesis platform on both GE and Hologic systems. “Breast density plays a critical role in both risk assessment and accuracy, as mammography sensitivity is reduced to approximately 48% from an average of 98% in those women with dense breasts,” the company says. “Our cutting-edge technology rapidly produces consistent breast density results while reducing the risk of reader variability, enabling radiologists to more easily identify women who might benefit from additional screening.”