FDA Radiology AI Devices

breastscape v1.0 is an advanced software tool used with Olea Sphere 3.0 to assist breast imaging physicians and MRI technologists in analyzing breast MRI data. It provides visualization, semi-automatic lesion segmentation, kinetic curve analysis, and planning assistance for MR-guided breast biopsy procedures, helping clinicians detect and characterize breast lesions and plan interventions more effectively.

Transpara 1.7.0 is an AI software tool designed to assist physicians in interpreting breast imaging exams such as digital mammography and tomosynthesis. It uses deep learning algorithms to detect suspicious calcifications and soft tissue lesions, scoring their likelihood of malignancy to aid diagnosis and improve workflow. It processes images to highlight abnormal areas and provides exam-level cancer likelihood scores, supporting better identification of breast cancer indicators.

Saige-Q is a software tool that analyzes digital breast mammograms using artificial intelligence to identify exams that may contain suspicious findings suggestive of breast cancer. It helps radiologists prioritize these exams in their worklist, enabling faster review of potentially concerning cases. The tool provides passive notification codes but does not provide diagnostic decisions and supports both full-field digital mammography and digital breast tomosynthesis images.

ProFound AI Software V3.0 is an AI-based medical imaging software that aids radiologists by detecting and highlighting suspicious soft tissue densities and calcifications in 3D digital breast tomosynthesis images. It provides confidence scores that help clinicians identify potentially malignant findings more quickly and accurately during breast cancer screening and diagnosis.

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.

HealthMammo is an AI-enabled software tool designed to analyze 2D full-field digital mammograms to identify and flag suspicious findings. It assists radiologists by prioritizing mammogram cases in the PACS/worklist, helping clinicians review critical cases faster and improve workflow efficiency without replacing diagnostic evaluation.

MammoScreen is an AI-based software that assists physicians in interpreting full-field digital mammograms (FFDM) by identifying suspicious breast lesions such as soft tissue lesions and calcifications. It provides marks on the mammogram images alongside a suspicion score to help detect potential breast cancer, supporting radiologists during their reading process to improve cancer detection without replacing clinical judgment.

Transpara is an AI-powered software designed to assist physicians in interpreting full-field digital mammography and digital breast tomosynthesis exams. It highlights suspicious regions that may indicate breast cancer, providing scores that indicate the likelihood of malignancy. This helps radiologists improve detection accuracy and workflow efficiency while supporting clinical decisions during breast cancer screening.

Transpara is an AI-powered software designed to assist radiologists in detecting and diagnosing breast cancer from screening mammograms. It highlights suspicious soft tissue lesions and calcifications and provides likelihood scores for cancer presence, helping clinicians make more informed decisions during mammogram interpretation.

ProFound AI Software V2.1 is an AI-based software designed to assist radiologists in detecting soft tissue densities and calcifications in 3D digital breast tomosynthesis images. It highlights suspicious breast lesions by marking areas in the images and assigns confidence scores to help physicians identify likely malignant regions, supporting earlier and more accurate breast cancer diagnosis.