FDA Radiology AI Devices

TumorSight Viz is an automated radiological image processing software designed to assist clinicians by analyzing medical images for tumor-related information, potentially improving diagnosis and treatment planning for patients with tumors.

StrokeSENS ASPECTS Software Application by Circle Cardiovascular Imaging Inc. is a computer-assisted diagnostic tool designed to assist clinicians in evaluating lesions suspicious for cancer, potentially improving diagnostic accuracy in radiology.

Sonix Health is a software product designed to analyze echocardiography ultrasound images automatically. It helps clinicians by classifying ultrasound views and measuring cardiac parameters using AI, thereby improving efficiency and accuracy in heart assessment for adult patients.

The Dreem 3S is a wearable headband device that records brain electrical activity (EEG) and movement data during sleep. It uses AI algorithms based on neural networks to automatically analyze this data and produce detailed sleep stage reports for adults. This helps clinicians assess sleep patterns and disturbances remotely in home or healthcare environments.

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems by Siemens are advanced diagnostic ultrasound devices that provide detailed imaging and signal data inside the body for clinical diagnosis. They are intended for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and pediatric imaging. These systems integrate AI-powered tools such as AI Abdomen for semi-automated view classification and measurement in abdominal ultrasound, and Trace AI for semi-automated measurements of anatomical structures in cardiac imaging, improving efficiency and accuracy for clinicians.

Koios DS is an artificial intelligence software tool that helps trained physicians analyze ultrasound images of breast lesions and thyroid nodules. It processes user-selected regions within the images to provide AI-derived risk assessments for cancer, and generates descriptors following established medical lexicons to improve diagnostic accuracy and reduce variability among physicians. The software also functions as an image viewer and supports image annotation and reporting, helping clinicians make more informed decisions in managing patients with suspicious lesions.

EchoGo Amyloidosis (1.0) is an automated AI decision support system that analyzes 2D echocardiograms (specifically apical four chamber view) to screen for cardiac amyloidosis in adults over 65 years with heart failure. It helps clinicians by classifying patients as suggestive or not suggestive of cardiac amyloidosis, enabling referral for confirmatory testing. The AI was trained on large datasets and validated clinically to ensure accuracy and safety.

Fetal EchoScan is an AI-powered software tool that assists physicians in analyzing fetal heart ultrasound videos during the second trimester. It helps identify suspicious anatomical findings that may indicate fetal congenital heart defects, enhancing diagnostic accuracy and aiding clinical decision-making without replacing standard care.

Frontier X Plus is a wearable ECG event recorder that monitors heart rhythms by capturing single-channel ECG signals via a chest strap. It automatically analyzes the ECG data using an embedded algorithm to detect arrhythmias such as atrial fibrillation, bradycardia, and tachycardia. The device helps clinicians monitor and diagnose heart conditions in adult patients, particularly those with suspected or known cardiac issues, by storing and transferring ECG data for physician review.

Ascent Cardiorespiratory Diagnostic Software is a standalone application used with hardware to measure, collect, and analyze lung and cardiopulmonary function tests. It helps clinicians, such as pulmonologists and cardiologists, diagnose lung and heart-related conditions by processing test data from devices like spirometers and body plethysmographs. The software provides detailed pulmonary and cardiopulmonary metrics, manages diagnostic data, and facilitates interpretation and reporting, improving diagnostic workflow.