FDA Clears Ceribell’s Clarity™ Algorithm for Pediatric Patients, Making Ceribell the First and Only FDA-Cleared AI Technology for Detection of Electrographic Seizures in Patients Ages 1 Ye...
CeriBell, Inc. (CBLL)
Company Research
Source: GlobeNewswire
SUNNYVALE, Calif., April 15, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next generation Ceribell Clarity™ algorithm for the detection of electrographic seizures in patients ages 1 and older. This makes Ceribell the first and only AI-powered point-of-care EEG system cleared to detect electrographic seizures in children as young as 1 year old and to fully cover the age range from 1 year old to adult.1 Using Ceribell’s comprehensive solution, clinicians will be empowered to detect non-convulsive seizures in pediatric patients in real time, supporting rapid diagnosis and treatment to help prevent serious brain injury in one of the most common neurological emergencies that children face.2 Based on Ceribell’s assessment, its Clarity
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CBLL
News
- CeriBell (NASDAQ:CBLL) had its "buy" rating reaffirmed by analysts at BTIG Research.MarketBeat
- AI Diagnostics Hit Critical Mass as Hospitals Race to Cut CostsPR Newswire
- CeriBell (NASDAQ:CBLL) had its "buy" rating reaffirmed by analysts at Cowen Inc.MarketBeat
- Ceribell Receives FDA 510(k) Clearance for First-of-its-Kind Delirium Monitoring SolutionGlobeNewswire
- Ceribell Receives FDA 510(k) Clearance for Use of Clarity? Algorithm for NeonatesGlobeNewswire
CBLL
Earnings
- 11/4/25 - Beat
CBLL
Sec Filings
- 12/15/25 - Form 144
- 12/12/25 - Form 8-K
- 12/11/25 - Form 4
- CBLL's page on the SEC website