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 & adult pts using same Ceribell EEG headbands already cleared for all ages in emergency & ICU setting
Ref: Globenewswire | Image: Ceribell
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