FDA Radiology AI Devices

The Uscan by EchoNous, Inc. is a handheld diagnostic ultrasound system designed for non-invasive imaging of the human body, including abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging. It also features automated bladder volume measurement, assisting clinicians in quickly and accurately assessing patients without invasive procedures.

EchoMD Automated Ejection Fraction Software by Bay Labs, Inc. is an AI-powered tool that analyzes previously acquired cardiac ultrasound images to automatically calculate the left ventricular ejection fraction, assisting clinicians in cardiac evaluation by providing streamlined, automated measurements integrated with DICOM-compatible PACS systems.

The Clarius Ultrasound Scanner is a portable, wireless ultrasound imaging system designed for diagnostic use across multiple body regions. It connects via Wi-Fi to mobile devices, allowing healthcare professionals to visualize real-time, high-resolution ultrasound images and fluid flow analysis in diverse clinical applications such as fetal, abdominal, cardiac, musculoskeletal, and more. This device facilitates medical imaging in varied clinical environments by enabling image acquisition on tablets and smartphones.

The Ventripoint Medical System Plus (VMS+) is an advanced ultrasound image analysis device that works alongside existing ultrasound systems. It digitally records and processes 3D ultrasound images to help clinicians evaluate the volumes and functions of the heart's left and right ventricles as well as the left and right atria. This aids in detailed cardiac assessment, providing valuable information on heart chamber sizes and function, which supports diagnosis and management of cardiac conditions.

Venue is a general-purpose diagnostic ultrasound system designed for use by qualified healthcare professionals in various clinical settings including critical care, emergency rooms, and outpatient offices. It supports multiple ultrasound imaging applications for different body regions, facilitating imaging, measurement, and analysis of human body structures and fluid, thereby aiding clinical diagnosis and interventional procedures.

The BladderScan Prime PLUS System is a non-invasive ultrasound device that measures the volume of urine in the bladder using patented neural network technology. It assists clinicians by providing real-time bladder volume measurements and directional aiming feedback to improve patient management and care.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system designed for diagnostic imaging and fluid flow analysis across a broad range of clinical applications including ophthalmic, fetal, abdominal, cardiac, musculoskeletal, and more. It wirelessly connects to iOS or Android devices, enabling clinicians to acquire high-resolution real-time ultrasound images and Doppler flow data for enhanced diagnostic evaluation and procedural guidance.

SmartTarget is a software system designed to assist physicians during image-guided prostate procedures by enhancing visualization. It processes 2D transrectal ultrasound images by performing 3D reconstruction and fusing these images with diagnostic scans like MRI or CT. This helps doctors accurately target and navigate instruments during biopsies, ablations, and other treatments, improving procedure precision and patient outcomes.

AmCAD-UV is a software tool designed to analyze flow Doppler ultrasound images by classifying ultrasonic color intensity data into different pulsatile signals. It helps clinicians visualize and evaluate vascular pulsatility by providing color-coded images and trend charts of pulsatile signals, although it is not intended for primary diagnostic use by itself.

ClearView cCAD is an AI-powered software tool that helps physicians analyze breast ultrasound images by automatically classifying lesion shape and orientation characteristics. It supports better screening and diagnosis by generating reports compliant with ACR BI-RADS standards, aiding radiologists in their assessment without replacing primary diagnostic interpretation.