FDA Radiology AI Devices

TOMTEC-ARENA is a clinical software package designed for reviewing, quantifying, and reporting medical imaging data primarily related to cardiovascular, fetal, and abdominal structures. It helps clinicians assess structures and functions from various imaging modalities in multiple dimensions, facilitating disease diagnosis through detailed quantifications and advanced visualization tools.

Syngo.via RT Image Suite is a medical imaging software tool that helps clinicians visualize and manipulate 3D and 4D images from multiple modalities like CT, PET, and MRI in preparation for radiation therapy treatments. It provides advanced contouring tools including AI-based automatic organ segmentation, multi-modality image fusion, and supports creating treatment plans to improve accuracy and efficiency in radiation therapy workflows.

EyeArt is an AI-powered medical software that analyzes retinal images to automatically detect more than mild diabetic retinopathy and vision-threatening diabetic retinopathy in adults with diabetes. It is designed to assist healthcare providers in primary care and eye care settings by providing rapid and reliable detection using color fundus images captured by specified retinal cameras.

AI-Rad Companion Engine is a software platform that supports visualization and post-processing of medical images for diagnostic use, helping clinicians by facilitating measurement, analysis, and data management. It integrates with multiple imaging modalities and PACS systems, providing an interface to add additional AI-driven clinical processing extensions.

AI-ECG Tracker is software designed to assist healthcare professionals in hospitals by automatically analyzing ambulatory ECG data to detect and assess cardiac arrhythmias in adults. It processes ECG waveforms, detects specific ECG features like QRS complexes and ectopic beats, measures intervals and heart rate, and provides advisory interpretations to support clinical diagnosis of arrhythmias, but not as the sole diagnostic tool.

The Biograph Horizon is a medical imaging system that combines positron emission tomography (PET) and computed tomography (CT) to provide detailed metabolic and anatomical images of the body. It helps clinicians in detecting, diagnosing, and monitoring diseases such as cancer, cardiovascular, and neurological disorders by fusing high-resolution functional and anatomical data, thereby improving treatment planning and clinical decision-making.

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, and Halcyon are integrated tools designed to help clinicians manage, plan, and deliver radiation therapy treatment. The software supports radiation therapy plan management and adaptive treatment planning, while the radiotherapy systems deliver precise radiation treatment using image guidance to treat lesions and tumors anywhere in the body. These tools aim to improve the accuracy and effectiveness of radiotherapy for patients, including adults and pediatric patients.

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.

The 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is a stereotaxic image-guided navigation system that assists surgeons in performing precise cranial surgery. It provides real-time tracking of instruments, image registration with preoperative scans, and step-by-step guidance for biopsies and ventricular catheter placement, improving surgical accuracy and safety.

MEDIP PRO is a medical imaging software that helps clinicians by processing CT and MRI images. It provides tools for segmenting images, improving image quality, and creating 3D reconstructions that can be exported for 3D printing to aid in preoperative planning. The software is intended to be used alongside other diagnostic tools and clinical judgement to support treatment planning.