FDA Radiology AI Devices

RhythmAnalytics is a software tool that analyzes single-lead ECG data to detect cardiac arrhythmias and measure heart-related signals. It helps healthcare professionals by providing supportive interpretations and can be integrated with other devices or platforms to assist clinicians in diagnosing heart rhythm disorders.

The Study Watch by Verily Life Sciences LLC is a wearable ECG monitoring device that records and securely transmits single-channel ECG waveforms. It assists healthcare professionals in tracking heart rhythms of adult patients with known or suspected heart conditions by enabling remote ECG data collection and review via a web portal.

Embrace is a wearable device worn on the wrist that monitors physiological signals such as Electrodermal Activity, motion, and temperature to detect generalized tonic clonic seizures in patients with epilepsy. It helps alert caregivers by sending notifications during seizure events, assisting in timely monitoring and care for patients both at home and in healthcare facilities.

The FFRangio System is an AI-based software device used to analyze standard angiographic images (X-ray based) of coronary arteries. It generates a 3D computer model from these images to simulate blood flow and calculate FFRangio, a measure that helps clinicians assess coronary artery disease functionally. It aids in clinical decision-making by providing detailed physiological information during catheterization procedures without invasive measurements.

PowerLook Tomo Detection V2 Software by iCAD Inc. is an AI-based computer-assisted detection and diagnosis tool that helps physicians identify suspicious lesions and calcifications in digital breast tomosynthesis images. It provides confidence scores to assist in evaluating findings, improving radiologist accuracy and reducing reading time during breast cancer screening exams.

Transpara is an AI-powered software tool that helps doctors identify suspicious areas in mammograms that might be breast cancer. It highlights these areas, provides scores indicating the likelihood of cancer, and supports physicians in making more accurate diagnoses. This assists in earlier and more reliable detection of breast cancer during screening.

Quantitative Total Extensible Imaging (QTxI) is a software tool that helps medical professionals manage and evaluate digital medical images from CT and PET scans. It supports tasks such as storing, retrieving, and displaying images, as well as identifying and analyzing regions of interest (ROIs) in full or partial body scans with 3D visualization. This software aids clinicians by automating quantification and monitoring changes in imaging data to improve diagnostic and treatment decision workflows.

The Uscan by EchoNous, Inc. is a handheld diagnostic ultrasound system designed for non-invasive imaging of the human body, including abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging. It also features automated bladder volume measurement, assisting clinicians in quickly and accurately assessing patients without invasive procedures.

EchoMD Automated Ejection Fraction Software by Bay Labs, Inc. is an AI-powered tool that analyzes previously acquired cardiac ultrasound images to automatically calculate the left ventricular ejection fraction, assisting clinicians in cardiac evaluation by providing streamlined, automated measurements integrated with DICOM-compatible PACS systems.

HealthCCS is a software tool that uses cardiac CT images to automatically identify and measure calcified plaques in the coronary arteries. This helps physicians assess coronary artery disease risk by providing a calcium score and risk category report based on pre-existing CT scans, aiding further clinical decisions and patient management.