FDA Radiology AI Devices

MammoScreen BD is an AI-powered software designed to assist radiologists by automatically analyzing mammography images. It helps detect and assess breast density, improving the accuracy and consistency of breast cancer screening and diagnosis.

Genius AI Detection 2.0 is a software tool that uses artificial intelligence and deep learning to help radiologists detect and evaluate potential breast abnormalities in 3D mammography (digital breast tomosynthesis) images. It marks suspicious soft tissue densities and calcifications, provides confidence scores, and supports radiologists in their interpretation during the exam reading, enhancing breast cancer screening accuracy and efficiency.

HESTIA is a full field digital mammographic x-ray system designed to assist clinicians in capturing detailed breast images for screening and diagnosis. This technology helps detect breast abnormalities, making it a valuable tool in breast cancer diagnosis and management.

MammoScreen® is an AI-based software designed to assist radiologists in detecting and diagnosing lesions that may be indicative of breast cancer from mammography images. It helps improve accuracy and efficiency by highlighting suspicious areas, supporting earlier and more reliable cancer detection.

Saige-Density is a software tool that analyzes digital mammography and breast tomosynthesis images to categorize breast density according to the ACR BI-RADS Atlas 5th Edition. It aids radiologists by providing adjunctive information to help assess breast tissue composition, improving the evaluation process, although it is not a diagnostic aid itself.

Saige-Dx (3.1.0) is an AI-based software designed to assist radiologists by analyzing digital breast tomosynthesis mammograms to detect suspicious soft tissue lesions and calcifications indicative of cancer. It evaluates 3D and 2D mammogram images, assigning suspicion levels for findings and cases, and produces reports to support concurrent reading. This helps clinicians improve detection accuracy and reduce reading time in breast cancer screening for women aged 35 and older.

Transpara (2.1.0) is an AI software tool designed to assist doctors during screening mammography and digital breast tomosynthesis exams. It analyzes breast images to detect suspicious calcifications and soft tissue lesions and provides scores indicating the likelihood of cancer. This helps clinicians improve detection accuracy and workflow, but decisions should not be made solely on its output.

Saige-Dx by DeepHealth, Inc is an AI-powered software that assists radiologists by automatically analyzing DBT mammograms and associated 2D images to detect potential soft tissue lesions and calcifications that might indicate breast cancer. It provides suspicion levels for findings and the entire case to support physicians during screening mammogram interpretation, improving diagnostic accuracy and efficiency.

ProFound Detection V4.0 is an AI-powered software designed to assist radiologists by detecting suspicious soft tissue densities and calcifications in 3D digital breast tomosynthesis (DBT) images. It helps identify potential malignant lesions by marking findings and providing confidence scores, thus supporting earlier and more accurate breast cancer detection during image interpretation.

Lunit INSIGHT DBT v1.1 is an AI-powered software designed to assist physicians in detecting and characterizing suspicious breast lesions in digital breast tomosynthesis exams. It marks regions of potential cancer with abnormality scores to aid diagnosis, improving clinical workflow for breast cancer screening in women.