FDA Radiology AI Devices

The Acumen Hypotension Prediction Index (HPI) Feature Software is a clinical decision support tool that uses arterial blood pressure waveform data and patient demographics to predict the likelihood that a patient will experience hypotension within 15 minutes. It provides clinicians real-time, adjunctive physiological insights to help anticipate and manage hypotensive events in operating room patients with advanced hemodynamic monitoring.

ContaCT is an AI-powered software developed by Viz.AI that analyzes brain CT angiogram images to detect suspected large vessel occlusions, a critical cause of stroke. The software notifies specialists quickly, allowing for faster clinical review and potentially earlier treatment, which can reduce disability from stroke. It integrates into hospital workflows, sending alerts in parallel to standard care without replacing diagnostic decisions.

QuantX is a software tool that helps radiologists analyze breast MRI images by automatically segmenting lesions and calculating a score based on lesion characteristics. It compares lesions in a patient's MRI to a database of known cases to help in diagnosing breast abnormalities, potentially improving diagnostic accuracy and consistency. It supports viewing multimodal images and generates structured reports to assist clinical decision-making.

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.