FDA Radiology AI Devices

BriefCase is an artificial intelligence software that automatically analyzes CT chest with contrast scans to detect suspected cases of aortic dissection. It helps hospital networks and medical specialists by flagging possible cases to prioritize workflow and speed up patient triage. It provides notifications with preview images for informational use, aiding clinicians in prompt attention to urgent cases without replacing standard diagnostic procedures.

Aorta-CAD is an AI-powered software tool designed to assist physicians in analyzing chest X-rays. It detects and highlights areas that may show aortic calcification or dilation, which can indicate chronic aortic conditions. This helps radiologists by drawing attention to suspicious regions, improving diagnostic accuracy without replacing physician judgment.

The Study Watch with Irregular Pulse Monitor by Verily Life Sciences is a wearable device designed for adults diagnosed with or at risk for atrial fibrillation (AF). It continuously monitors heart rhythms using photoplethysmography (PPG) and single-channel ECG measurements. The device notifies users of irregular pulses, prompting ECG collection, and securely transmits data for healthcare provider review. This aids early detection and monitoring of AF, enabling timely clinical intervention.

ElucidVivo A.3 is a medical image analysis software that processes and visualizes CT angiographic images to help physicians assess arterial vessels and stratify patients with atherosclerosis. It offers tools for measurement and visualization of vessel structure and plaque characteristics, supporting clinical decision-making without providing direct diagnosis.

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.