FDA Radiology AI Devices

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 SpectralMD DeepView Wound Imaging System 2.0 is a medical imaging device that uses non-contact photoplethysmography (PPG) technology to capture color images showing blood perfusion in tissues. It helps clinicians assess blood flow in a variety of clinical settings, including wound healing, plastic surgery, and vascular surgery, by providing detailed images of microcirculation in healthy or injured skin.

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.

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.

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.

The Personalized Physiology Analytics Engine software is a computerized analysis tool designed to monitor changes in a patient's vital signs relationships over time. Using data such as heart rate, respiratory rate, and activity, it calculates a Multivariate Change Index that helps clinicians track significant physiological changes during routine monitoring, aiding in patient assessment but not for direct diagnostic decisions.