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Ceribell Gains FDA Clearance for Seizure Detection Algorithm

Story Highlights
  • Ceribell received FDA clearance for its Clarity algorithm for detecting seizures in neonates.
  • The clearance enables rapid bedside detection, addressing a critical gap in neonatal care.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Ceribell Gains FDA Clearance for Seizure Detection Algorithm

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Ceribell, Inc. ( (CBLL) ) has shared an update.

On November 24, 2025, Ceribell, Inc. announced that the FDA granted 510(k) clearance for its ClarityⓇ algorithm, making it the first FDA-cleared seizure detection algorithm for pre-term neonates through adults. This clearance addresses a critical gap in neonatal care by enabling rapid bedside detection and treatment of non-convulsive seizures, potentially improving outcomes for high-risk newborns. The clearance was supported by data from over 700 patients, marking the largest validation dataset for neonatal seizure detection, and highlights the importance of timely intervention in neonatal care.

The most recent analyst rating on (CBLL) stock is a Buy with a $20.00 price target. To see the full list of analyst forecasts on Ceribell, Inc. stock, see the CBLL Stock Forecast page.

Spark’s Take on CBLL Stock

According to Spark, TipRanks’ AI Analyst, CBLL is a Neutral.

Ceribell, Inc. shows strong revenue growth and positive market momentum, but faces challenges with profitability and valuation. The earnings call provided positive future guidance, yet increased operating expenses and net loss remain significant concerns.

To see Spark’s full report on CBLL stock, click here.

More about Ceribell, Inc.

Ceribell, Inc. is a medical technology company based in Sunnyvale, California, focused on transforming the diagnosis and management of patients with serious neurological conditions. The company has developed the Ceribell System, a point-of-care electroencephalography (EEG) platform designed for rapid diagnosis and continuous monitoring of neurological conditions, particularly in acute care settings. Ceribell’s system, which combines portable hardware with AI-powered algorithms, is FDA-cleared for detecting suspected seizure activity and is used in intensive care units and emergency rooms across the U.S.

Average Trading Volume: 297,551

Technical Sentiment Signal: Hold

Current Market Cap: $566.1M

Learn more about CBLL stock on TipRanks’ Stock Analysis page.

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