FDA Radiology AI Devices

Stone Clear is a medical device that uses ultrasound imaging to locate urinary stones in the upper urinary tract and applies focused ultrasound pulses to reposition these stones, helping patients pass them more easily after lithotripsy treatment. It provides real-time image guidance and therapy, improving stone management and patient outcomes.

FEops HEARTguide is a software tool that helps clinicians simulate and plan the implantation of left atrial appendage occlusion devices in individual patients. By using CT scans to create patient-specific heart models and incorporating device mechanics, it predicts how the device will deform and interact with the tissue, aiding pre-procedural decision-making to improve procedural outcomes and device placement.

Caption Guidance is an AI software accessory for ultrasound systems that helps clinicians, including those without specialized training, acquire high-quality cardiac ultrasound images. It provides real-time feedback and prescriptive guidance to optimize the capture of diagnostic standard 2D echocardiographic views, supporting quicker and more reliable heart assessments.