FDA Radiology AI Devices

ClearView cCAD is an AI-powered software tool that helps physicians analyze breast ultrasound images by automatically classifying lesion shape and orientation characteristics. It supports better screening and diagnosis by generating reports compliant with ACR BI-RADS standards, aiding radiologists in their assessment without replacing primary diagnostic interpretation.

The Ahead 300 is a portable, non-invasive medical device that records and analyzes brain electrical activity to assist clinicians in evaluating patients with closed head injuries. It provides algorithm-based classifications of structural brain injury and measures brain function and cognitive performance to support diagnosis and treatment decisions, particularly to aid in deciding on the necessity of head CT scans.

The BrainScope Ahead 200 is a portable EEG device designed to aid physicians in evaluating patients with mild traumatic brain injury by measuring and analyzing brain electrical activity. It supports clinical decision-making regarding the need for head CT scans by providing objective quantitative EEG parameters. The device is intended for use as an adjunct to standard clinical practice and includes features such as continuous impedance monitoring and cognitive assessment tools for military use. It helps clinicians by providing rapid brain activity data to support the assessment of brain injury severity without replacing imaging such as CT scans.

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.