FDA Radiology AI Devices

Rho is a machine learning software that analyzes standard frontal x-rays of various body parts in patients aged 50 and older to identify possible low bone mineral density. It helps radiologists by generating reports suggesting patients who may benefit from further clinical bone health assessment, thereby assisting in early detection and management of bone health issues.

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.

Caption Interpretation Automated Ejection Fraction Software is an AI-powered tool that processes cardiac ultrasound images to automatically estimate the left ventricular ejection fraction, a critical measure of heart function. It helps clinicians quickly and accurately evaluate cardiac health by analyzing ultrasound video clips, selecting the best quality views, and calculating ejection fraction with confidence metrics. This supports clinical decision-making in adult cardiac evaluations.

Caption Guidance is an AI software accessory for ultrasound systems that helps clinicians, including those without specialized training, acquire high-quality cardiac ultrasound images. It provides real-time feedback and prescriptive guidance to optimize the capture of diagnostic standard 2D echocardiographic views, supporting quicker and more reliable heart assessments.

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.

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.