FDA Radiology AI Devices

Clarify DL is a software solution that uses deep learning integrated with iterative image reconstruction techniques to reduce noise and improve image quality in Nuclear Medicine bone SPECT images. It helps clinicians by enhancing image clarity which potentially improves diagnostic confidence and patient outcomes.

HealthJOINT is a software product that assists clinicians by using artificial intelligence to create 3D models of knee bones from standard 2D X-ray images. This helps surgeons with preoperative planning for knee surgeries by providing detailed anatomical landmarks and accurate bone reconstructions, improving clinical assessment and surgical preparation.

The Ventripoint Medical System Plus (VMS+) 3.0 is a software and hardware system that works as an adjunct to ultrasound imaging. It records and analyzes 2D ultrasound images to reconstruct a 3D model of the heart's four chambers, helping clinicians measure heart chamber volumes and ejection fractions. This aids in cardiac assessment by providing detailed and accurate cardiac volume measurements using advanced image analysis techniques.