FDA Radiology AI Devices

The REMI-AI Rapid Detection Module (REMI-AI RDM) is an AI-based seizure detection software integrated into the REMI Remote EEG Monitoring System. It analyzes EEG data in near real-time to notify clinicians of potential electrographic seizures, aiding in patient evaluation by marking events in the EEG record. It is intended for use in non-ICU healthcare settings with adult and pediatric patients (6+ years).

Ascent Cardiorespiratory Diagnostic Software is a standalone application used with hardware to measure, collect, and analyze lung and cardiopulmonary function tests. It helps clinicians, such as pulmonologists and cardiologists, diagnose lung and heart-related conditions by processing test data from devices like spirometers and body plethysmographs. The software provides detailed pulmonary and cardiopulmonary metrics, manages diagnostic data, and facilitates interpretation and reporting, improving diagnostic workflow.

The Cerebral Autoregulation Index (CAI) Algorithm is a software tool designed to help clinicians monitor whether cerebral autoregulation—the brain's ability to maintain stable blood flow—is intact or impaired. It analyzes signals from cerebral oximetry and blood pressure monitors to provide an index value indicating the level of coherence between these parameters. This helps guide advanced hemodynamic monitoring in critical care patients without making direct therapeutic decisions.

cvi42 Software Application is a medical imaging software developed by Circle Cardiovascular Imaging Inc. that supports clinicians by enabling viewing, post-processing, and quantitative analysis of cardiovascular magnetic resonance (MR) and computed tomography (CT) images. It uses semi-automated machine learning algorithms to assist in measuring cardiac function, vessel characteristics, and calcified plaques, helping medical professionals in diagnostic decision-making related to heart and adjacent vessels.

The syngo Application Software is a medical imaging software developed by Siemens that enables real-time viewing, manipulation, 3D visualization, communication, and postprocessing of medical images. It supports diagnostic review and image-guided interventional procedures across multiple imaging modalities and clinical applications, improving workflow and aiding clinicians in diagnosis and treatment planning.

Limbus Contour is a software tool designed to help medical professionals automatically create accurate contours of healthy anatomical structures from CT and MRI images. These contours are used to plan and evaluate radiation treatment for cancer patients, improving efficiency and consistency in treatment preparation.

QUADSENSE is a surgical tool used during total knee replacement surgery to help surgeons measure and compare the forces in the patellofemoral joint before and after patella resurfacing. The device includes a sensor attached to the patella and displays real-time force data to support surgical decision-making, improving joint alignment and implant positioning.

The Zeta Cranial Navigation System is a stereotaxic image guidance system designed to help neurosurgeons spatially position and orient surgical instruments during cranial surgery. It uses 3D preoperative CT or MRI scans to assist in real-time navigation without requiring rigid fixation of the patient. This system enhances the precision of neurosurgical procedures by providing visual guidance based on medical imaging data.

Sourcerer is a software tool designed for neurologists and EEG technologists to visualize brain activity by integrating EEG data with MRI images. It helps localize sources of brain activity by projecting EEG signals onto an idealized head model, aiding in clinical diagnoses such as epilepsy evaluation.

Encevis (2.1) is a software tool that assists neurologists by automatically analyzing EEG recordings to detect seizures, spikes, electrographic status epilepticus, and other brain activity patterns. It reduces artifacts in EEG data, provides quantitative measures like frequency bands and burst suppression, and displays alerts to support rapid clinical decision-making, especially in acute care settings.