FDA Radiology AI Devices

The LVivo Software Application is an AI-based software platform that automatically analyzes ultrasound images, primarily of the heart's left and right ventricles, to evaluate cardiac function, and also measures bladder volume. It supports both global and segmental evaluation of cardiac structures, providing clinicians with valuable measurements like ejection fraction and myocardial strain, helping diagnose and monitor heart disease and other medical conditions.

The 16ch Flex SPEEDER Medium and Large 1.5T coils are receive-only, 16-channel phased array coils designed to be used with Canon 1.5T MRI systems. These coils help produce high-quality diagnostic images of general human anatomy, assisting clinicians in accurately interpreting MRI scans for patient diagnosis.

The Epredia E1000 Dx Digital Pathology Solution is an automated system that creates, views, and manages digital images of surgical pathology slides prepared from formalin-fixed paraffin-embedded tissue. It helps pathologists interpret tissue samples digitally, providing an alternative to traditional light microscopy and improving workflow and diagnostic accuracy in pathology labs.

Myomics is a software tool designed to assist clinicians in viewing, processing, and quantitatively analyzing cardiovascular magnetic resonance (MR) images. Using AI-powered algorithms, it helps in detailed assessment of heart structures and adjacent vessels to support diagnosis in adult patients based on images acquired from 3.0 T MR scanners.

ChestView US is an AI software product that analyzes frontal and lateral chest X-rays to detect and mark suspicious areas such as lung nodules, pleural abnormalities, mediastinal/hilar abnormalities, and consolidations. It provides annotated images with highlighted regions to assist clinicians in reading chest radiographs, improving diagnostic accuracy as a concurrent reading aid.

aiCockpit AI Viewer is a stand-alone software for clinicians that allows viewing and interacting with medical images and AI annotations within a web browser. It supports various imaging manipulation tools and 3D rendering, helping radiologists review findings effectively by displaying images alongside clinical documents and reports.

The Makoto Intravascular Imaging System™ is a medical imaging device that uses near-infrared spectroscopy combined with intravascular ultrasound to examine coronary and peripheral arteries. It helps clinicians detect lipid-core plaques, assess coronary artery lipid burden, and identify patients at risk of cardiac events by providing detailed images and compositional information of blood vessels. The device includes software that automatically identifies vessel borders and guide catheter locations, aiding in precise and efficient vascular assessment during invasive angiographic procedures.

The Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are medical devices designed to assist in the revascularization of patients experiencing acute ischemic stroke caused by large vessel occlusions in the brain. The catheter is used alongside a compatible aspiration pump to remove blood clots from the affected neurovasculature, helping to restore blood flow. This device is intended for use within 8 hours of stroke symptom onset and for patients who have not responded to or are ineligible for thrombolytic drug therapy.

The Pilot TLS system helps healthcare providers accurately position central venous catheters by real-time monitoring of the patient's cardiac electrical signals. This serves as an alternative to traditional chest X-ray or fluoroscopy confirmation methods, potentially reducing radiation exposure and speeding up catheter placement.

The Ventripoint Medical System Plus (VMS+) 4.0 is a software and hardware system that works alongside ultrasound machines to create 3D heart chamber models from 2D ultrasound images. This helps clinicians measure volumes and ejection fractions of the left and right ventricles and atria, improving assessment of cardiac function. The system uses AI-based reconstruction algorithms and manual control point adjustments to ensure accurate 3D modeling, providing detailed volumetric data and clinical reports.