FDA Radiology AI Devices

The CLEWICU System is a software platform that uses AI machine learning models to predict the likelihood of future hemodynamic instability in adult patients in various hospital critical care units. It integrates patient data from electronic health records and monitoring devices to help clinicians assess a patient's risk of clinical deterioration or stability, providing valuable physiological insights as an aid to clinical judgment.

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 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 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.

LungQ v3.0.0 is a software tool that helps physicians analyze CT scans of the lungs by automatically segmenting lung structures, measuring lung volumes and densities, evaluating fissures, and generating reports. It supports diagnosis and monitoring of lung conditions by providing quantitative assessments from CT scans, streamlining clinical workflows.

DASI Dimensions (V1.0) is a clinical decision support software that processes multiphase CTA chest images to generate automated measurements of cardiovascular structures. It helps cardiologists and radiologists by providing detailed images and numerical data to support planning for aortic valve replacement procedures, improving accuracy and efficiency of pre-operative assessments.

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.

VEA Align is a cloud-based software developed by EOS imaging that uses 2D X-ray images acquired from EOS imaging systems to assist healthcare professionals in assessing global alignment in orthopedic patients. It applies machine learning algorithms to automatically place anatomical landmarks on images, helping clinicians analyze spinal deformities, degenerative diseases, and lower limb disorders with precise angle and length measurements. It supports both pediatric and adult patients and enhances clinical decision-making through interactive landmark adjustment and comparison to normative values.

The Butterfly iQ3 Ultrasound System is a portable, hand-held ultrasound device used by trained healthcare professionals to capture diagnostic ultrasound images and measurements across multiple clinical areas such as cardiac, abdominal, lung, musculoskeletal, fetal/obstetric, and more. It offers various imaging modes and supports professional use in diverse healthcare environments, helping clinicians visualize anatomical structures and fluids for adult and pediatric patients.

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.