FDA Radiology AI Devices

Velacur is a portable ultrasound elastography device designed to assist clinicians in the assessment of liver diseases. It non-invasively measures liver tissue stiffness and fat content by analyzing shear wave speed and ultrasound attenuation, helping in the management of conditions such as hepatic steatosis. The device incorporates AI algorithms to improve image quality and accuracy of liver tissue characterization.

EdgeFlow UH10 is a handheld ultrasound device designed to noninvasively measure urine volume in the bladder. It uses deep learning AI to detect and outline the bladder in ultrasound images, calculates bladder volume, and displays results on its touchscreen. It supports both B-mode and harmonic imaging, helping healthcare professionals quickly assess bladder volume accurately and efficiently.

Velacur is a portable ultrasound device that measures the stiffness and attenuation of liver tissue by generating and analyzing shear waves using ultrasound imaging. It incorporates AI-based algorithms to assist clinicians in assessing liver disease by providing detailed tissue characterization, enhancing accuracy and ease of use at the point of care in clinics and hospitals.

The Auto 3D Bladder Volume Tool by Butterfly Network is a software application integrated with Butterfly Network ultrasound systems. It uses machine learning (U-Net convolutional neural network) to automatically segment and measure bladder volume from ultrasound images, providing clinicians with noninvasive quantitative data to support diagnosis in adult patients.