par John R. Fischer
, Senior Reporter | December 03, 2020
The FDA has given Hologic the green light to begin the sale of its Genius AI Detection technology, a deep-learning-based software designed to help radiologists identify subtle potential cancers in breast tomosynthesis scans.
The company announced the clearance during the virtual 2020 Radiological Society of North America Annual Meeting, and says that it will aid in early detection of breast cancer when used with the Genius 3D Mammography exam.
“The AI makes sure that anything of interest remains in those slices so you’re not losing any of the resolution or data,” Jen Meade, president of the breast and skeletal health division at Hologic, told HCB News. She adds that it helps “to improve reading time and overall efficiency without compromising on image detection.”
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In addition to standard-resolution tomosynthesis, the Genius AI Detection software is the only 3D CAD solution that supports Hologic’s Clarity HD and 3D Quorum tomosynthesis technology.
The software highlights areas with subtle potential cancers that can be difficult for a radiologist to detect in further examination. It is designed to do this using a higher sensitivity and a false-positive rate that is lower than that of Hologic’s previous generation CAD products.
It also provides key metrics at the time of image acquisition to help radiologists categorize and prioritize cases based on complexity and expected reading time. This optimizes workflow and may shorten time spans between screening and diagnostic follow-up. “The algorithm behind it will identify for radiologists those that are very likely not something that has a finding, and they can pass through them, versus those that are going to require more attention and focus for the BI-RADs reads.”
The Genius AI Detection technology is the only commercially-available deep learning product to run on the acquisition workstation of the mammography system without the need for a separate server. “It’s less hardware you need to have there and it’s also more secure. It’s just one less transmission you have to make in that environment.”
The Genius AI Detection technology is specifically designed for use with the Genius 3D Mammography Exam. The Genius 3D Mammography exam is only available on the Hologic 3D Mammography system and consists of a 2D and 3D image set.