FDA Radiology AI Devices

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.

CINA-VCF is an AI-powered software device designed to analyze chest and abdominal CT scans in patients aged 50 and above to identify suspected vertebral compression fractures. It operates alongside standard imaging workflows to prioritize and notify clinicians of potentially positive cases, helping improve triage speed and efficiency without altering original images or serving as a diagnostic tool itself.

VinDr-Mammo is a software tool designed to assist radiologists in prioritizing mammogram exams by flagging those that may contain suspicious findings. It analyzes 2D digital mammograms using artificial intelligence to identify potentially concerning cases and alerts radiologists, enabling more efficient workflow and faster patient care. It does not replace the physician's final diagnosis.

RAYDENT SW is software that helps dental professionals plan treatments and design orthodontic and prosthetic devices by using 3D imaging data and simulations. It assists in creating treatment plans and designing devices such as clear aligners, crowns, veneers, and bridges, improving precision and efficiency in dental care.

Heuron ICH is an artificial intelligence software that assists medical specialists by analyzing non-contrast head CT images to identify suspected cases of intracranial hemorrhage. It provides notifications and compressed preview images to help prioritize patient care and streamline workflow, without modifying the original images or serving as a diagnostic device.

SmartChest is an AI software that analyzes frontal chest X-rays to detect suspected pleural effusion and pneumothorax. It helps radiologists by prioritizing cases with critical findings in their worklists, improving workflow efficiency. The software passively notifies the radiologist without replacing clinical decision-making.

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is an AI-powered software that automatically analyzes CT angiography scans of the chest region to detect signs of acute aortic syndrome, including aortic dissection and intramural hematoma. It helps radiologists prioritize and triage cases by flagging suspicious studies, enabling faster diagnosis and improved workflow efficiency, although it is not a substitute for clinical decision-making.

syngo.CT Brain Hemorrhage by Siemens Medical Solutions is an AI-powered software that helps radiologists prioritize CT scans suspected of having intracranial or subarachnoid hemorrhages. It analyzes head CT images to flag cases for earlier review, improving workflow efficiency. This software is not for diagnosis but supports clinicians by highlighting urgent cases based on AI detection of hemorrhages.

CINA-iPE is an AI-powered software that analyzes contrast-enhanced CT scans (not dedicated CTPA) to help detect incidental pulmonary embolisms. It flags suspected positive cases in real-time to assist radiologists in prioritizing patients and improving workflow efficiency. It operates alongside standard care without altering original images and provides informative preview notifications but does not replace diagnostic review.

OTS Hip is a surgical system designed to assist orthopedic surgeons in planning and performing total hip arthroplasty (hip joint replacement) surgeries. It uses CT images of the patient's hip anatomy to create a detailed 3D model, enabling precise preoperative planning and real-time intraoperative navigation. This image-guided system improves surgical accuracy and helps position compatible hip prostheses according to the pre-planned locations, enhancing patient outcomes.