Ceribell Receives FDA 510(k) Clearance for Use of Clarity? Algorithm for Neonates
CeriBell, Inc. (CBLL)
Company Research
Source: GlobeNewswire
SUNNYVALE, Calif., Nov. 24, 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 Clarity? algorithm to detect electrographic seizures in newborns pre-term and older. This clearance makes the Ceribell System the first and only AI-powered point-of-care electroencephalography (EEG) technology available to detect electrographic seizures in all ages of patients, from pre-term neonates through adults. Early detection of seizures represents a critical unmet need in neonatal care. While approximately 9% of neonatal intensive care unit (NICU) patients may be diagnosed with seizures,2,3 research suggests that up to 90% go undetected without EEG monitoring.4 As a result, a significant portion of NICU patients could benefit from e
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News
- Ceribell to Participate in the Piper Sandler 37th Annual Healthcare ConferenceGlobeNewswire
- Ceribell to Participate in the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services ForumGlobeNewswire
- CeriBell (NASDAQ:CBLL) had its price target lowered by analysts at JPMorgan Chase & Co. from $21.00 to $17.00. They now have an "overweight" rating on the stock.MarketBeat
- CeriBell (NASDAQ:CBLL) had its price target lowered by analysts at TD Cowen from $36.00 to $20.00. They now have a "buy" rating on the stock.MarketBeat
- Ceribell Reports Third Quarter 2025 Financial ResultsGlobeNewswire
CBLL
Earnings
- 11/4/25 - Beat
CBLL
Sec Filings
- 12/5/25 - Form 4
- 12/4/25 - Form 144
- 12/4/25 - Form 4
- CBLL's page on the SEC website