Ceribell, Inc. receives FDA clearance for its Clarity Ⓡ algorithm to detect electrographic seizures in newborns pre-term and older.
The clearance makes Ceribell System the first and only AI-powered point-of-care EEG technology for seizure detection in all age groups.
This development addresses the critical need for timely seizure detection in neonatal care.
510(k) Clearance for Clarity Algorithm
Ceribell receives FDA 510(k) clearance for its AI-powered Clarity Ⓡ algorithm to detect seizures in neonates through adults.
Significance of Early Detection
Early detection of seizures is crucial in neonatal care to prevent poor outcomes and long-term disability.
Ceribell's Validation Dataset
Ceribell's clearance was supported by EEG data from over 700 patients, the largest dataset used for neonatal seizure detection.
Recommendations for Continuous EEG Monitoring
Recent guidelines from medical societies emphasize the need for continuous EEG monitoring in high-risk neonates for timely intervention.
Importance of Timely Intervention
Timely seizure detection and treatment are essential to protect newborns from serious brain injury and ensure long-term development.
- The clearance enables rapid bedside detection and diagnosis of non-convulsive seizures in neonatal intensive care units (NICUs).
- Expanded EEG screening capabilities can benefit a significant portion of NICU patients by providing timely monitoring and treatment.
- Ceribell's technology addresses the gap in 24/7 access to EEG in NICUs, offering real-time insights for prompt bedside neurological assessment.
Ceribell's FDA clearance for the Clarity Ⓡ algorithm marks a significant milestone in neonatal care, enhancing seizure detection and management for better patient outcomes. The innovative technology empowers clinicians with real-time insights to protect newborns' delicate brains.