FDA Radiology AI Devices

See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is an AI-powered software that assists medical professionals in analyzing thyroid ultrasound images by automatically localizing thyroid nodules and characterizing them using standardized descriptors based on ACR TI-RADS. It helps clinicians generate structured reports and improves accuracy in detection and classification of nodules, thereby supporting clinical decision-making in thyroid nodule management.

BU-CAD is a software application designed to assist physicians by analyzing breast ultrasound images to identify and evaluate soft tissue lesions suspicious for breast cancer. It highlights regions of interest and provides malignancy scores and BI-RADS classifications to support clinical decision-making. It also supports viewing of mammography images and includes tools for image adjustment and documentation, helping improve diagnostic accuracy and efficiency.