FDA Radiology AI Devices

SMART Bun-Yo-Matic X-Ray is a software tool that uses X-ray images of the foot and ankle to create 3D mathematical models, provide radiographic measurements, and assist orthopedic healthcare professionals in diagnosis and surgical planning. The software visualizes patient anatomy and orthopedic fixation devices, enabling precise pre-surgical planning to improve treatment outcomes for foot and ankle conditions such as hallux valgus.

Tyto Insights for Crackles Detection is an AI-powered software that analyzes lung sound recordings made by a compatible stethoscope to detect abnormal lung sounds called crackles. It supports clinicians by providing automated detection to help evaluate lung health in both adults and children aged two years and older. The device aids healthcare providers in clinical decision-making by highlighting recordings suggestive of crackles, which may indicate underlying lung conditions.

Hyper Insight - ICH is an AI-powered clinical software tool that analyzes brain CT scans to detect suspected intracranial hemorrhage. It provides timely notifications to medical specialists to prioritize patient care, helping clinicians triage potential emergencies more efficiently. The software serves as a supplementary notification aid rather than a definitive diagnostic tool, enhancing workflow efficiency and supporting faster treatment decisions.

VEA Align and spineEOS are cloud-based medical imaging software products by EOS imaging designed to assist healthcare professionals. VEA Align helps assess spinal and lower limb alignment using 2D X-rays with AI-generated anatomical landmarks for precise angle and length measurements. spineEOS facilitates preoperative planning for spine surgeries with access to 3D spine datasets and clinical measurements, enabling tailored surgical strategies. Both tools support clinicians by improving diagnostic accuracy and surgical planning through advanced image analysis and AI.

The O-arm O2 Imaging System by Medtronic Navigation, Inc is a mobile X-ray device designed to provide detailed 2D and 3D imaging of patients' bony anatomy and metallic objects, mainly used during image-guided surgeries. It includes advanced software features such as metal artifact reduction and dose reduction using machine learning, helping clinicians obtain clearer images with lower radiation exposure for improved surgical navigation and patient safety.

Medihub Prostate is a semi-automatic image processing software designed for analyzing prostate MR images. It uses AI to outline the prostate region semi-automatically and supports radiologists and urologists in reviewing MR data. The software requires user editing and confirmation, enhancing the accuracy of prostate volume measurements and analysis, aiding clinical decision-making without replacing the expert's judgment.

Tempus ECG-AF is an AI-powered software that analyzes standard 12-lead ECG recordings from patients aged 65 and older to detect signs indicating an increased risk of atrial fibrillation or atrial flutter within the next 12 months. It assists clinicians by providing risk notifications based on ECG data, improving early identification of patients who may require further diagnostic follow-up.

The V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. is a general-purpose diagnostic ultrasound system that acquires ultrasound data and displays it in multiple modes including 2D, Doppler, and 3D/4D. It helps healthcare professionals with imaging and fluid flow analysis across many clinical applications such as fetal, cardiac, abdominal, and musculoskeletal imaging. The system includes AI-based features such as NerveTrack for nerve segmentation, enhancing diagnostic capabilities.

SMART Bun-Yo-Matic CT is an AI-based software tool that helps orthopedic healthcare professionals by automatically segmenting foot and ankle bones from CT images, creating 3D anatomical models, measuring structures, and providing surgical planning visualizations. This supports diagnosis and treatment planning, especially for conditions like hallux valgus, through detailed, interactive reports and templates.

Clarius OB AI is an AI-powered software integrated into the Clarius Ultrasound system that assists healthcare professionals in measuring fetal biometric parameters such as head circumference and femur length using ultrasound images. It automates the detection and measurement process, helping clinicians make accurate assessments during obstetric ultrasound examinations.