FDA Radiology AI Devices

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.

autoSCORE is a software tool that assists neurologists by automatically analyzing EEG recordings to identify and categorize abnormal brain activity such as epileptiform and non-epileptiform abnormalities. It acts as a decision support system, marking potential abnormal areas on EEG data, thereby helping clinicians review EEGs more efficiently and accurately. The device does not provide final diagnostic conclusions but rather supports professional judgment in interpreting EEG results.

The REMI AI Discrete Detection Module (REMI-AI DDM) is a software tool designed to assist physicians qualified in EEG interpretation by automatically identifying and marking sections of EEG recordings that may correspond to seizure-like events. It processes previously acquired EEG data collected via the REMI Remote EEG Monitoring System, helping speed up and improve the review process for EEG data in patients aged 6 years and older. The software does not provide diagnostic conclusions but serves as an aid to clinicians in seizure detection support.

The Ceribell Status Epilepticus Monitor is a software medical device that analyzes EEG data captured from a headband device to automatically detect electrographic status epilepticus in patients at risk of seizures. It provides timely diagnostic support to clinicians in acute care environments, enabling faster treatment decisions for this critical neurological condition.