FDA Radiology AI Devices

HeartSee Cardiac P.E.T. Processing Software is a tool that helps trained clinicians analyze heart PET images to quantify blood flow and heart function. It provides detailed maps and measurements that assist in diagnosing coronary artery disease by measuring myocardial perfusion and coronary flow reserve. This enables better clinical interpretation and patient management based on quantitative PET imaging data.

The Pilot TLS system helps healthcare providers accurately position central venous catheters by real-time monitoring of the patient's cardiac electrical signals. This serves as an alternative to traditional chest X-ray or fluoroscopy confirmation methods, potentially reducing radiation exposure and speeding up catheter placement.

The Etiometry Platform is a software solution designed for use in intensive care settings to help healthcare professionals monitor and assess cardiovascular and respiratory conditions in adult, pediatric, and neonatal patients. It collects real-time physiological and laboratory data remotely from various bedside devices, displays this data, and calculates risk indices like oxygen delivery adequacy and ventilation status. This assists clinicians in timely clinical decision-making without requiring new hardware.

The Sonicaid Team3 is a fetal monitoring system designed for non-invasive and invasive monitoring of fetal and maternal physiological parameters during pregnancy. It helps clinicians assess fetal well-being through ultrasound, fetal heart rate monitoring, and includes the Dawes-Redman CTG analysis software to evaluate cardiotocographs, aiding in the identification of abnormal or reassuring fetal heart patterns.

TipTraQ is a wearable fingertip device designed to assist in evaluating and diagnosing sleep apnea in adults. It collects physiological data like photoplethysmogram (PPG) and movement via accelerometer, then uses cloud-based AI algorithms to analyze the data and determine critical sleep parameters such as total sleep time, REM time, and apnea-hypopnea index. This helps clinicians diagnose sleep apnea more efficiently both at home and in clinical settings.

TBS iNsight (V4) is a software tool that processes bone density images from DXA scans to calculate a Trabecular Bone Score (TBS). This score helps clinicians assess bone quality and fracture risk, complementing standard bone density measurements. The software improves the accuracy of evaluating osteoporosis and bone health, aiding in diagnosis and treatment monitoring.

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.

Noxturnal Web is a web-based software designed to display, analyze, and manually score pre-recorded physiological data collected during sleep studies. It assists clinicians in diagnosing sleep and respiratory-related disorders by enabling detailed review and reporting of sleep stages and breathing events such as obstructive apneas, all under clinical supervision.

Saige-Density is a software tool that analyzes digital mammography and breast tomosynthesis images to categorize breast density according to the ACR BI-RADS Atlas 5th Edition. It aids radiologists by providing adjunctive information to help assess breast tissue composition, improving the evaluation process, although it is not a diagnostic aid itself.

The Cardiac Workstation 5000 and 7000 by Philips Medizin Systeme Böblingen GmbH are advanced electrocardiograph devices designed for healthcare professionals to acquire, analyze, and store multi-channel ECG signals from adult and pediatric patients. These devices use clinically proven algorithms to provide measurements, graphical presentations, and interpretive statements to support clinical decision-making in hospitals and cardiology clinics.