FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

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.

FDA #
K231779
Product Code
OMB
Page 1 of 11 results
1

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.