Hologic receives FDA clearance for deep learning tool to detect potential breast cancers

Dec. 3, 2020

Hologic announced the U.S. Food and Drug Administration (FDA) clearance and commercial availability of the company’s Genius AI Detection technology, a new deep learning-based software designed to help radiologists detect subtle potential cancers in breast tomosynthesis images, according to a press release from the company. 

Hologic said studies showed that the Genius AI Detection software aids in the identification and early detection of breast cancer when used with the Genius 3D Mammography exam. 

The new technology highlights areas with subtle potential cancers that can be difficult to detect for further examination by the radiologist. The new tool is designed to provide higher sensitivity and a false-positive rate that is much lower than Hologic’s previous generation CAD products. 

The new software delivers key metrics at the time of image acquisition to help radiologists categorize and prioritize cases by complexity and expected read time in order to optimize workflow and expedite patient care, according to Hologic. 

Hologic has the release.