FDA Radiology AI Devices

OsteoDetect is an AI-driven software that helps clinicians detect distal radius fractures on adult wrist X-rays. It analyzes both posterior-anterior and lateral radiographs, highlighting potential fractures with bounding boxes to assist healthcare providers in diagnosing wrist injuries more accurately and quickly. The software serves as an adjunct, supporting clinical decision-making but not replacing the clinician's judgment.

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.