FDA Radiology AI Devices

The Acumen Hypotension Prediction Index (HPI) Feature Software is a clinical decision support tool that uses arterial blood pressure waveform data and patient demographics to predict the likelihood that a patient will experience hypotension within 15 minutes. It provides clinicians real-time, adjunctive physiological insights to help anticipate and manage hypotensive events in operating room patients with advanced hemodynamic monitoring.

The Rooti Rx System is a wearable single-lead ECG recording device that allows patients to record ECG data at home or work. The data is stored on the device and later transmitted via Wi-Fi to medical professionals’ iOS devices for post-analysis, aiding clinicians in patient cardiac monitoring and diagnosis.

The Peerbridge Cor System is a wearable ECG monitoring device designed for continuous recording and transmission of heart electrical activity over 24 hours to 7 days. It helps clinicians monitor patients with symptoms like palpitations or dizziness by generating ECG reports based on FDA-cleared algorithms, aiding clinical diagnosis.

The CardioLogs ECG Analysis Platform is a software tool that helps qualified healthcare professionals analyze ECG data to assess arrhythmias in adults. It supports uploading ECG recordings from various devices, processes them using a proprietary proprietary algorithm to detect heartbeats and rhythm abnormalities, and provides analysis results as an advisory support to clinicians. This cloud-based platform helps improve ECG interpretation efficiency and accuracy.

The syngo Application Software by Siemens is a versatile medical imaging software that allows clinicians to view, manipulate, and process medical images in real time. It supports diagnostic image review and various interventional procedures by providing image-guided navigation, fusion of ultrasound with fluoroscopy, and 3D visualization to improve anatomical orientation and procedural accuracy. This software helps clinicians streamline complex procedures and enhances treatment planning and control.

Arterys Cardio DL is an AI-powered software that analyzes cardiovascular MRI scans to quantify blood flow and heart function. It helps cardiologists and radiologists by providing clinically relevant, reproducible quantitative data from MRI images, supporting clinical decision-making without giving direct medical advice.

HeartFlow FFRct is a software tool that analyzes previously acquired coronary CT images to simulate coronary blood flow and pressure, aiding clinicians in evaluating coronary artery disease without additional invasive procedures. It provides functional assessment by generating fractional flow reserve values to support clinical decision-making alongside other diagnostic information.

The LVivo Software Application is a medical software that analyzes echocardiographic ultrasound videos to automatically detect and measure the left ventricular wall and function of the heart. It helps clinicians assess cardiac function by calculating metrics like ejection fraction and myocardial strain, thus aiding in cardiac diagnosis and management.

HeartFlow FFRct is a software tool that analyzes existing CT images of coronary arteries to calculate fractional flow reserve (FFRCT). This helps clinicians assess the functional significance of coronary artery disease non-invasively, aiding diagnosis and treatment decisions without requiring additional imaging or radiation.