FDA Radiology AI Devices

Eko Low Ejection Fraction Tool (ELEFT) is an AI-based software device that analyzes ECG and heart sound recordings to help clinicians identify patients with reduced left ventricular ejection fraction (LVEF ≤ 40%), a marker of potential heart failure. It is intended for use on adults at risk of heart failure and supports referral decisions for further testing like echocardiography, without replacing diagnostic procedures.

SleepStageML is a software-only medical device that uses AI to automatically analyze EEG signals from sleep studies (PSG recordings) to identify different sleep stages. It assists qualified clinicians in diagnosing sleep quality and sleep disorders in adult patients by providing automated, software-generated sleep stage annotations that clinicians can review and verify.

Rapid (6.0) by iSchemaView, Inc. is a medical imaging software designed to process and analyze dynamic and functional imaging data from CT and MRI scans. It aids clinicians by providing advanced visualization, quantification, and analysis tools to help select acute stroke patients for treatment, enhancing diagnostic confidence and workflow efficiency.

The GI Genius system by Cosmo Artificial Intelligence is an AI-powered tool that helps doctors detect colonic mucosal lesions, such as polyps and adenomas, in real time during routine white-light endoscopy exams. It enhances lesion detection by analyzing live endoscopy video and highlighting areas of interest on the gastrointestinal tract on the display, supporting clinicians in making accurate diagnoses during colonoscopy procedures.

The Biograph VK10 is a combined Positron Emission Tomography (PET) and Computed Tomography (CT) scanner that provides fused images of both physiological function and anatomical structure. It assists healthcare providers in detecting, localizing, diagnosing, staging, and restaging various diseases such as cancer, cardiovascular and neurological disorders. The system supports single modality and combined PET/CT imaging and can aid in treatment planning and lung cancer screening in high-risk populations.

The SurgiCount+ System by Stryker Instruments is a multifunctional software application designed to assist clinicians in estimating blood loss during surgery by analyzing images of used surgical sponges. It uses AI algorithms to estimate hemoglobin mass and blood volume on sponges and incorporates RFID technology to count and locate surgical sponges, improving surgical item management and patient safety.

autoSCORE is a software tool that assists neurologists by automatically analyzing EEG recordings to identify and categorize abnormal brain activity such as epileptiform and non-epileptiform abnormalities. It acts as a decision support system, marking potential abnormal areas on EEG data, thereby helping clinicians review EEGs more efficiently and accurately. The device does not provide final diagnostic conclusions but rather supports professional judgment in interpreting EEG results.

The REMI AI Discrete Detection Module (REMI-AI DDM) is a software tool designed to assist physicians qualified in EEG interpretation by automatically identifying and marking sections of EEG recordings that may correspond to seizure-like events. It processes previously acquired EEG data collected via the REMI Remote EEG Monitoring System, helping speed up and improve the review process for EEG data in patients aged 6 years and older. The software does not provide diagnostic conclusions but serves as an aid to clinicians in seizure detection support.

ART-Plan is a radiotherapy treatment planning software that assists clinicians by visualizing and fusing multimodal medical images, automatically segmenting organs and lymph nodes using AI, generating synthetic CT images from MR and CBCT scans, computing dose distributions for radiation therapy, and aiding in treatment adaptation decisions. It enhances workflow efficiency and accuracy for trained professionals managing radiotherapy for cancer patients.

uOmnispace.MI is an advanced software platform designed to help healthcare professionals view and analyze medical images from PET, CT, MR, and SPECT scans. It facilitates tasks such as image registration, lesion segmentation, and statistical analysis, supporting clinical workflows in oncology, neurology, and cardiology. The software integrates multiple applications including fusion imaging, dynamic analysis, brain scan quantification, and cardiac function analysis, thereby assisting clinicians in making timely and accurate diagnoses.