FDA Radiology AI Devices

The Low Ejection Fraction AI-ECG Algorithm by Anumana, Inc. is a software tool that analyzes 12-lead ECG signals using AI to aid in screening for patients with low left ventricular ejection fraction (≤ 40%). It helps clinicians identify adults at risk of heart failure to decide if further cardiac evaluation is needed. It works quickly on routine ECGs and does not replace diagnostic imaging but supports clinical judgment.

Volta AF-Xplorer is a medical software device that helps doctors analyze and annotate electrical signals from the heart in real-time. It uses machine learning to detect areas in the atria that exhibit abnormal electrical patterns during atrial fibrillation or tachycardia, supporting catheter ablation procedures. This software integrates with cardiac mapping systems to improve the precision and efficiency of cardiac electrophysiology interventions.

The OFIX MIS App is a mobile software application designed to help healthcare professionals view, store, and measure images to plan orthopedic surgeries, specifically for spinal implant procedures. It uses images captured via a mobile phone camera to assist in selecting the correct rod length for pedicle screw spinal systems, aiding surgeons in making precise implant placement decisions.

EFAI RTSUITE CT HCAP-Segmentation System is an AI-powered software tool designed to assist radiation oncology professionals by automatically outlining critical organs at risk on CT scans. It helps radiation therapists plan treatments more efficiently by providing initial organ contours that clinicians can review and adjust, improving workflow while ensuring safety and accuracy.

Annalise Enterprise CTB Triage Trauma is an AI-based software tool that assists clinicians by analyzing non-contrast brain CT scans to detect signs of vasogenic edema. It helps prioritize cases with suspected findings for earlier review, improving workflow efficiency in medical imaging departments.

Annalise Enterprise CTB Triage Trauma is an AI software tool designed to analyze non-contrast brain CT scans and assist clinicians by prioritizing cases with features suggestive of mass effect. It integrates with image and order management systems to notify users for earlier review, improving workflow efficiency without replacing clinical decision-making.

qXR-CTR is an AI-powered software that helps physicians automatically measure the cardiothoracic ratio—the size of the heart relative to the chest—using chest X-ray images. It analyzes images to provide quick, accurate measurements that support clinical decision-making, making the process more efficient for healthcare providers.

Jazz is a semi-automatic medical image processing software designed to assist physicians in labeling, visualizing, and measuring volumes of brain structures from MRI scans. It is intended for use with patients diagnosed with multiple sclerosis or brain metastases, enabling physicians to review, correct, and confirm segmentations before generating radiological reports, thereby supporting clinical workflows for brain imaging analysis.

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.

Aquilion Serve (TSX-307A/1) V1.3 is a whole-body multi-slice helical CT scanner that captures detailed cross-sectional volume images including the head. It incorporates AiCE, an AI-powered noise reduction algorithm using deep convolutional neural networks to improve image quality and reduce noise. This helps clinicians obtain clearer images for specialized studies across multiple anatomical regions, aiding diagnosis and treatment planning while potentially reducing radiation dose.