Ceribell Receives FDA 510(k) Clearance for First-of-its-Kind Delirium Monitoring Solution
CeriBell, Inc. (CBLL)
Company Research
Source: GlobeNewswire
SUNNYVALE, Calif., Dec. 09, 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 proprietary delirium monitoring solution,1 the first and only FDA cleared delirium screening and monitoring device. This clearance further establishes the Ceribell System as an AI-powered brain monitoring platform technology, extending the benefits to a larger population of critically ill patients and providing additional information to assist in diagnosing patients at risk for both seizures and delirium. “Delirium has severe consequences for critically ill patients, including increased mortality, prolonged hospital stays, and long-term cognitive impairment, resulting in substantial burdens for families and healthcare systems,” said Juliana Barr, MD, profes
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CBLL
News
- 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 Use of Clarity? Algorithm for NeonatesGlobeNewswire
- 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
CBLL
Earnings
- 11/4/25 - Beat
CBLL
Sec Filings
- 12/12/25 - Form 8-K
- 12/11/25 - Form 4
- 12/11/25 - Form SCHEDULE
- CBLL's page on the SEC website