FDA clears Hologic's Genius AI Detection technology for breast cancer

Hologic announced Tuesday that its Genius AI Detection technology, a deep learning-based software designed to help radiologists detect subtle potential cancers in breast tomosynthesis images, gained FDA clearance.

Jennifer Meade, president of the breast and skeletal health solutions division, remarked that "not only did studies show that Genius AI Detection aids in image interpretation by highlighting suspicious, and often subtle, areas of interest, it also provides the radiologist the opportunity to prioritise the most concerning patient cases." She added that this is "a real game changer as it has the potential to shorten the cycle between screening and diagnostic follow-up, and ultimately improve patient outcomes."

Delivers key metrics at imaging

According to Hologic, the new software delivers key metrics at imaging to help radiologists categorise and prioritise cases by complexity and expected read time, optimising workflow and expediting patient care. The technology "highlights areas with subtle potential cancers that can be difficult to detect for further examination by the radiologist, and is designed to provide higher sensitivity and a false-positive rate much lower than Hologic's previous generation CAD products," the company said.

Hologic also pointed to studies demonstrating that the deep-learning algorithm can help radiologists spot breast cancer in its early stages when used with the company's Genius 3D Mammography exam. Further, it noted that the Genius AI Detection software is the only 3D CAD solution that supports its FDA-approved Clarity HD and 3DQuorum imaging technologies, in addition to standard-resolution tomosynthesis.

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