FDA Radiology AI Devices

The uAngio AVIVA CX is an advanced angiographic X-ray system designed to assist clinicians during diagnostic, interventional, and surgical procedures such as cardiac and neuro-angiography. It provides precise, intelligent image guidance with 2D and 3D imaging capabilities and software features such as camera-assisted recognition and voice control, helping to improve procedural accuracy and patient safety.

The Intracavitary/Interstitial System by Varian Medical Systems is a medical device used in cancer treatment for the uterus, cervix, and vagina. It employs HDR or PDR brachytherapy, guiding radioactive sources via hollow catheters and needles for precise radiation delivery, helping clinicians target tumors effectively while minimizing exposure to surrounding tissues.

Kosmos by EchoNous, Inc. is an imaging system that uses pulsed Doppler ultrasound technology to assist radiology professionals in medical imaging. It helps clinicians by providing detailed ultrasound images for diagnostic purposes involving blood flow and tissue imaging.

The Neu Platform is a smartphone application and clinician dashboard system designed to remotely measure and quantify tremor severity in patients aged 45 or older with mild to moderate Parkinson's Disease. It collects motion data via smartphone accelerometers, allowing patients to perform motor assessments and report symptoms remotely, while clinicians can review this data in a secure web portal to monitor and manage the patient's condition more effectively.

Lung AI (LAI001) is a software tool that assists healthcare professionals by analyzing lung ultrasound scans to detect signs of consolidation/atelectasis and pleural effusion. It highlights regions of interest on ultrasound cine clips to help clinicians identify potential lung issues, improving review efficiency but not replacing clinical judgment or other diagnostic tests. It supports physicians particularly in emergency departments during point-of-care lung ultrasounds.

Annalise Enterprise is an artificial intelligence software designed to analyze chest X-ray images to detect several critical findings such as pneumothorax, tension pneumothorax, pleural effusion, pneumoperitoneum, and vertebral compression fractures. It supports clinicians by prioritizing studies containing these suspected findings to streamline and accelerate patient care workflow, aiding in triage and worklist management.

The Dynamis Robotic Surgical System is a robotic platform designed to assist surgeons in precisely locating anatomical structures and guiding surgical instruments during spine surgeries. It uses real-time tracking and intraoperative CT images to navigate and position surgical tools accurately, especially for placing spinal pedicle screws in the thoracic, lumbar, and sacral regions. This helps improve surgical accuracy and patient safety.

EchoGuide is a portable 3D ultrasound imaging device designed to assist healthcare providers in identifying the proper vascular access points on the skin for patients with arteriovenous fistulas or grafts. It automates ultrasound imaging acquisition and displays live coronal plane images to guide clinicians during cannulation, improving accuracy and ease of use during the procedure.

The eHertz Functional Series Diagnostic Ultrasound System by eSonic Technology is a portable ultrasound imaging device designed for general diagnostic use across adults, pregnant women, and pediatric patients. It supports multiple imaging modes including B-mode, Doppler, and elastography among others, enabling healthcare professionals to visualize and analyze the human body and fluid for various exams such as fetal, abdominal, cardiac, and musculoskeletal. This system enhances image quality through features like micro blood flow imaging and image optimization, aiding clinicians in making more accurate assessments.

MySpine WebPlanner is a web-based surgical preoperative planning software that assists orthopedic and neurosurgeons by allowing them to view, store, measure radiological images, and plan surgical placement of spinal fixation and fusion devices. It supports surgeons in preparing surgical plans by providing detailed imaging and implant positioning information, helping improve clinical decision-making before spinal surgery.