Ceribell's AI EEG monitor gets FDA Breakthrough designation for detecting strokes in hospital
The company will use its existing rapid-EEG headband with a new algorithm to spot large vessel occlusion strokes in hospitalized patients.
The FDA has granted Ceribell Breakthrough Device designation for an AI algorithm that analyzes EEG from its existing rapid-response headband to detect large vessel occlusion (LVO) strokes in hospitalized patients. LVOs are major blockages that need urgent treatment.
Strokes that happen inside the hospital are often noticed late. Continuous brain monitoring that flags them early could speed treatment, and it extends Ceribell’s EEG platform beyond seizure detection.