FDA Radiology AI Devices

The BrainScope Ahead 100 is a portable EEG-based device designed to assist physicians in evaluating patients with mild traumatic brain injury. It analyzes brain electrical activity to help decide if a head CT scan is needed, potentially reducing unnecessary CT scans and radiation exposure. The device processes EEG data using AI-driven algorithms to classify patients based on the likelihood of structural brain injury visible on CT.

Quantra is a software application used with digital breast x-ray images to calculate volumetric and area breast density. It aids radiologists by providing quantitative breast tissue composition data to help in consistent breast density reporting. It does not interpret images directly but supports breast cancer risk assessment and reporting.

QUANTRA is software designed for use with digital mammography systems to estimate volumetric breast density. It calculates the ratio of fibroglandular tissue to total breast volume from mammography images, providing quantitative data to assist radiologists in assessing breast tissue composition. The software acts as an adjunct tool and is not intended as a diagnostic or interpretive aid, helping clinicians better understand breast density which is important for patient care.

The BioPlex 2200 ANA Screen with Medical Decision Support Software (MDSS) is a laboratory tool that assists clinicians by analyzing patterns in antibody test results from human serum or plasma samples. Using AI principles (k-nearest neighbor algorithm), it compares patient antibody profiles against a large database to suggest associations with specific systemic autoimmune diseases such as lupus, scleroderma, Sjögren's syndrome, and polymyositis. This software helps improve diagnostic accuracy and guides additional testing decisions.