FDA Radiology AI Devices

ScreenDx is an AI-powered software device that analyzes lung CT scans to identify patterns suggestive of interstitial lung disease. It provides clinicians with a qualitative output to help refer patients who may benefit from further assessment of lung fibrosis, supplementing standard care workflows but not replacing diagnostic methods.

IQ-UIP is an AI-powered computer-aided software designed to analyze non-contrast chest CT scans to detect and notify specialists about radiological findings suggestive of usual interstitial pneumonia (UIP), a type of fibrotic lung disease. It works alongside standard radiological workflows to help clinicians by providing summarized findings via a worklist application, assisting in the evaluation of interstitial lung disease without altering original images or providing diagnostic conclusions itself.

Fibresolve is a software device that analyzes lung CT images using deep learning to identify patterns suggestive of idiopathic pulmonary fibrosis. It provides a binary output to assist clinicians in diagnosing fibrotic lung disease, serving as an adjunct tool in the diagnostic workflow especially before invasive testing, helping to improve early detection and referral for appropriate clinical discussion.