FDA grants breakthrough destination for Hologic’s cancer technology

2 December 2020 (Last Updated December 2nd, 2020 10:11)

The US Food and Drug Administration (FDA) has granted clearance to medical technology company Hologic’s new deep learning-based software, Genius AI Detection technology, for breast cancer.

FDA grants breakthrough destination for Hologic’s cancer technology
The software supports radiologists in detecting subtle potential cancers in breast tomosynthesis images. Credit: Difu Wu.

The US Food and Drug Administration (FDA) has granted clearance to medical technology company Hologic’s new deep learning-based software, Genius AI Detection technology, for breast cancer.

The technology is designed to support radiologists in detecting subtle potential cancers in breast tomosynthesis images.

The company also announced that the Genius AI Detection is now commercially available.

According to studies, Genius AI Detection software, when used along with the Genius 3D Mammography exam, facilitates identification and early detection of breast cancer.

It works by highlighting areas with subtle potential cancers that can be difficult for the radiologist to detect for further examination.

In addition, it can provide higher sensitivity and lower false-positive rate compared to Hologic’s older generation CAD products.

Hologic Breast and Skeletal Health Solutions division president Jennifer Meade said: “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 with an opportunity to prioritise the most concerning patient cases.

“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.”

The software delivers key metrics during image acquisition, supporting radiologists in categorising and prioritising cases by complexity and expected read time to improve workflow and accelerate patient care.

Genius AI Detection is the first product available in the market that runs on the acquisition workstation of the mammography system without requiring a separate server to offer a simple, convenient, and secure environment.

It is the only 3D CAD solution that supports Hologic’s recent innovations in tomosynthesis imaging, Clarity HD, 3DQuorum imaging technology, and standard-resolution tomosynthesis.