Genius AI Detection 2.0 with CC-MLO Correlation
Hologic, Inc.Genius AI Detection 2.0 with CC-MLO Correlation is an AI-powered software designed to assist radiologists by analyzing digital breast tomosynthesis images to detect and mark suspicious soft tissue densities and calcifications. It provides confidence scores for each detected lesion, helping clinicians interpret breast cancer screening exams more effectively, including correlation between different standard mammographic views for better diagnosis workflow.
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 from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score. The device intends to aid in the interpretation of digital breast tomosynthesis exams in a concurrent fashion, where the interpreting physician confirms or dismisses the findings during the reading of the exam.
Technology
The device uses deep learning networks to analyze standard mammographic views in digital breast tomosynthesis exams. It outputs lesion location, lesion outline, and confidence scores for detected lesions, as well as a case score for the entire exam. Findings are packaged into a DICOM Mammography CAD SR object for display on compatible workstations. The new feature correlates a suspected lesion found in one view with a like finding in the other view (CC-MLO correlation), improving workflow and navigation for the interpreting physician.
Performance
Verification testing included software validation, integration, and system testing and demonstrated the software met its requirements. Standalone evaluation of the CC-MLO Correlation feature used a dataset of 106 biopsy-proven malignant cases and 561 screening negative cases, with expert radiologist ground truth marking. The evaluation showed the device is safe and effective in detecting soft tissue and calcification lesions and correlating findings between CC and MLO views.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/13/2023
4 months - 2
FDA Approval
5/23/2023
Other devices from Hologic, Inc.
- �Genius� Digital Diagnostics System with the Genius� Cervical AI algorithm�2024 • DE NOVO
- Genius AI Detection 2.02022 • 510K
- Genius AI Detection2020 • 510K
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