FDA Radiology AI Devices

The EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is software that uses deep learning to analyze left-hand X-ray images in pediatric patients aged 2 to 16 years. It estimates bone age to assist pediatric radiologists in clinical decision-making. The system integrates with existing PACS workflows, providing bone age assessments to support but not replace radiologist interpretation.

Corvair is an AI-powered software that analyzes resting ECG recordings to detect various heart rhythms, morphological abnormalities, and measure ECG intervals. It supports healthcare professionals by providing an initial automated interpretation of ECGs to assist in cardiac diagnosis, enhancing accuracy and efficiency in clinical settings.

LVivo IQS is an AI-powered platform designed to analyze ultrasound images of the heart, specifically providing real-time quality scoring of right ventricle images from the 4-chamber apical view. This software helps clinicians by automatically detecting, measuring, and calculating important cardiac parameters and providing feedback on image quality, enhancing the reliability and interpretability of ultrasound examinations.

DentalMonitoring is a medical software device that uses AI to analyze pictures of a patient's mouth taken via smartphone and proprietary hardware. It helps dental professionals remotely monitor orthodontic treatments by assessing oral hygiene, soft tissue, dental conditions, alignment, and occlusion. It provides 2D and 3D monitoring capabilities to track treatment progress safely and non-invasively.

The AEYE-DS device helps healthcare providers automatically detect more than mild diabetic retinopathy in adults with diabetes by analyzing retinal images taken by specific fundus cameras. It uses AI technology to analyze the images and provides diagnostic screening results, improving early detection and management of diabetic eye disease.

Rho is a machine learning software that analyzes standard frontal x-rays of various body parts in patients aged 50 and older to identify possible low bone mineral density. It helps radiologists by generating reports suggesting patients who may benefit from further clinical bone health assessment, thereby assisting in early detection and management of bone health issues.

APPRAISE-HRI is a mobile health app designed for military healthcare providers that uses vital signs like heart rate and blood pressure collected from an external monitor to assess and stratify the risk of hemorrhage in trauma patients. This helps medics identify individuals who need urgent care or evacuation by providing a continuous hemorrhage risk score in real-time, improving situational awareness and clinical decisions post-trauma.

The CorVista System with PH Add-On is a non-invasive AI-based medical device that analyzes sensor-acquired cardiac electrical and hemodynamic signals to indicate the likelihood of elevated pulmonary arterial pressure, aiding clinicians in diagnosing pulmonary hypertension. It provides results through a user-friendly digital interface and supports healthcare providers by combining the AI output with clinical judgment.

Eko Low Ejection Fraction Tool (ELEFT) is an AI-based software device that analyzes ECG and heart sound recordings to help clinicians identify patients with reduced left ventricular ejection fraction (LVEF ≤ 40%), a marker of potential heart failure. It is intended for use on adults at risk of heart failure and supports referral decisions for further testing like echocardiography, without replacing diagnostic procedures.

CINA-ASPECTS is a computer-aided diagnosis software designed to assist clinicians in evaluating brain tissue abnormalities using CT scans. It automatically analyzes regions of the brain affected by ischemic stroke, computes a standardized ASPECT score, and provides visual and quantitative data to support timely and accurate diagnosis of early acute stroke injury.