Genius AI Detection
Hologic, Inc.Genius AI Detection is an AI software designed to assist radiologists by automatically identifying potential abnormalities such as masses and calcifications in digital breast tomosynthesis exams. It highlights suspicious regions on breast images, provides confidence scores, and helps improve diagnostic accuracy and workflow efficiency for breast cancer screening and diagnosis.
Intended Use
Genius AI Detection is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthesis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in DBT exams and provide confidence scores that offer assessment for Certainty of Findings and a Case Score. It aids in the interpretation of digital breast tomosynthesis exams concurrently, where the interpreting physician confirms or dismisses findings during exam reading.
Technology
The device utilizes deep learning networks to analyze each standard mammographic view in a digital breast tomosynthesis exam, producing CAD results including lesion location, outline, and confidence scores. Findings are packaged in DICOM Mammography CAD SR objects for display on review workstations, supporting a concurrent reading workflow.
Performance
Performance was validated via a multi-reader multi-case (MRMC) clinical study with 390 cases (106 cancers). The average AUC improved from 0.794 without CAD to 0.825 with CAD. Sensitivity increased by 9%, and recall rate increased slightly. Standalone testing demonstrated comparable detection performance on standard and high resolution tomosynthesis images.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/17/2020
7 months - 2
FDA Approval
11/18/2020
Other devices from Hologic, Inc.
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