Ceribell Secures FDA Clearance for Quantitative EEG Trending and Amplitude-Integrated EEG Analysis

Shots: The US FDA has granted 510(k) clearance to a new software for the Ceribell System that converts raw EEG information into simplified easy-to-read trends, helping clinicians monitor changes in brain activity The update adds Alpha-Delta Ratio & Relative Alpha trending for detecting early signs of brain distress & reduced blood flow in high-risk pts,…

ByRidhi RastogiOctober 1, 2026

NEWS

Ceribell Secures FDA Clearance for AI-Powered EEG Enhancements

Shots: The US FDA has granted 510(k) clearance to two AI algorithm enhancements, Epileptiform Abnormality Detection & Artifact Reduction, which are integrated into its cloud-based Neurology Portal The Artifact Reduction algorithm identifies interference from patient movement, medical equipment, and physiological signals, while Epileptiform Abnormality Detection flags abnormal patterns across lengthy EEG recordings, helping neurologists navigate…

ByRidhi RastogiAugust 11, 2026

NEWS

Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Shots: The US FDA has granted 510(k) clearance to Clarity algorithm for the detection of electrographic seizures in pts (≥1yrs.) Pediatric clearance was backed by extensive electroencephalography (EEG) dataset developed from ~1,700 pts to detect non-convulsive seizures, ensuring rapid diagnosis & prevention of serious brain injury Clarity algorithm allows seizure detection in both pediatric &…

ByRidhi RastogiApril 17, 2025

Ceribell Secures FDA Clearance for AI-Powered EEG Enhancements

Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

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