FDA Radiology AI Devices

StrokeSENS ASPECTS Software Application by Circle Cardiovascular Imaging Inc. is a computer-assisted diagnostic tool designed to assist clinicians in evaluating lesions suspicious for cancer, potentially improving diagnostic accuracy in radiology.

Neurophet AQUA (V3.1) is an automated medical software that analyzes brain MR images to help doctors by labeling, visualizing, and measuring brain structures and lesions. It compares these measurements to reference data, enabling clinicians to assess brain changes or abnormalities more efficiently and accurately.

AiMIFY is a software that enhances contrast in brain MRI images after they have been taken, making lesions and other features easier for radiologists to see. It uses machine learning to improve image quality without requiring direct interaction with MRI machines, helping clinicians better identify abnormalities in the brain.

Overjet Periapical Radiolucency Assist is an AI-powered software designed to help dentists detect periapical radiolucencies in dental X-ray images, specifically on periapical radiographs. It provides automated, concurrent read assistance to improve diagnostic accuracy, supporting dentists in identifying potential issues in permanent teeth for patients aged 12 and older. The tool acts as a supplementary aid, enhancing clinical decision-making without replacing professional judgment.

Hepatic VCAR is a medical software designed to assist clinicians in analyzing liver CT scans by providing automated and editable 3D segmentation of the liver, liver lesions, and hepatic artery. It uses deep learning algorithms to improve accuracy, helping to assess liver morphology and changes over time, thereby facilitating faster and more precise liver evaluations.