FDA Radiology AI Devices

Navbit Rapid Surgical Plan is a software tool designed to assist surgeons in planning primary total hip replacement surgeries. It analyzes X-ray images of a patient's hip and spine to provide recommendations on the placement of hip replacement components, aiming to reduce complications. The software helps surgeons by offering data-driven guidance based on patient-specific anatomy and mobility.

XBeam (v2) is a software tool designed to calculate and validate the radiation dose or monitor units needed during external beam radiation therapy. It supports treatment planning for superficial and orthovoltage radiotherapy systems made by Xstrahl. By accurately calculating treatment parameters like beam-on time and dose, it helps ensure patients receive the prescribed radiation safely and accurately. The software is intended for use by trained medical physics professionals to improve the quality assurance of radiation treatments.

ClearRead CT CAC is software that helps physicians assess coronary artery calcification on non-contrast, non-gated chest CT scans. It automatically detects and quantifies calcified coronary lesions, providing an Agatston score and categorization to aid in cardiovascular risk assessment. This allows clinicians to efficiently obtain quantitative calcium scoring to help guide patient management, supplementing but not replacing clinical expert review.

Sonix Health is a software product designed to analyze echocardiography ultrasound images automatically. It helps clinicians by classifying ultrasound views and measuring cardiac parameters using AI, thereby improving efficiency and accuracy in heart assessment for adult patients.

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems by Siemens are advanced diagnostic ultrasound devices that provide detailed imaging and signal data inside the body for clinical diagnosis. They are intended for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and pediatric imaging. These systems integrate AI-powered tools such as AI Abdomen for semi-automated view classification and measurement in abdominal ultrasound, and Trace AI for semi-automated measurements of anatomical structures in cardiac imaging, improving efficiency and accuracy for clinicians.

Koios DS is an artificial intelligence software tool that helps trained physicians analyze ultrasound images of breast lesions and thyroid nodules. It processes user-selected regions within the images to provide AI-derived risk assessments for cancer, and generates descriptors following established medical lexicons to improve diagnostic accuracy and reduce variability among physicians. The software also functions as an image viewer and supports image annotation and reporting, helping clinicians make more informed decisions in managing patients with suspicious lesions.

Fetal EchoScan is an AI-powered software tool that assists physicians in analyzing fetal heart ultrasound videos during the second trimester. It helps identify suspicious anatomical findings that may indicate fetal congenital heart defects, enhancing diagnostic accuracy and aiding clinical decision-making without replacing standard care.

VINT is a software tool designed to assist clinicians in viewing, processing, and quantitatively evaluating cerebrovascular MRI images. It imports DICOM-formatted MR images and analyzes blood flow characteristics of cerebral arteries, including providing signal intensity gradient metrics from TOF-MRA scans. It supports advanced image corrections and data visualization, aiding radiologists in assessing cerebral artery health without the need for contrast medium.

EchoSolv AS is a cloud-based AI and machine learning decision support software designed to help cardiologists assess severe aortic stenosis (AS) from transthoracic echocardiogram data and patient demographics. It provides a categorical probability of severe AS to assist in diagnosis alongside clinical guidelines, improving identification accuracy and supporting patient management decisions during echocardiogram interpretation.

MammoScreen BD is an AI-powered software that helps radiologists evaluate breast tissue density in mammograms and digital breast tomosynthesis. It provides breast density categories based on established ACR BI-RADS standards. The tool offers supplementary information to aid radiologists in assessing breast density, supporting better screening decisions for women aged 40 and older. It processes DICOM images and integrates with clinical systems to assist interpretation without replacing physician judgment.