FDA Radiology AI Devices

The Zio ECG Utilization Software (ZEUS) System is a software platform that processes and analyzes long-term continuous ECG data collected from compatible cardiac monitoring devices. It helps clinicians by automatically detecting and reporting cardiac arrhythmias and other relevant heart rhythm information, assisting in the diagnosis and management of cardiac conditions.

Oxehealth Vital Signs is a software device that analyzes video images captured by standard cameras to noninvasively measure a patient's pulse rate and estimated breathing rate. It uses proprietary algorithms to monitor skin pixel intensity changes and chest wall movements, allowing healthcare staff to perform vital sign spot checks without disturbing the patient. This is especially useful in hospital or secured environments where minimizing patient contact is advantageous.

The Stethee Pro 1 is an electronic stethoscope designed for medical screening and diagnostic use. It detects and amplifies sounds from the heart, lungs, and other internal organs, and works with the Stethee Pro Software System to record, visualize, analyze, and share these sounds. This helps clinicians better assess patient heart and lung conditions through enhanced audio and data analysis tools.

The Study Watch with Irregular Pulse Monitor is a wearable device that records, stores, and transmits single-channel ECG rhythms to help detect irregular pulses such as atrial fibrillation in adults. It uses proprietary electrodes and PPG sensors to collect physiological data, which can be reviewed by healthcare professionals via a web portal to support diagnosis and patient monitoring.

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.

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.

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 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.