Ceribell, Inc. secured 510(k) clearance from the U.S. Food and Drug Administration on November 24, 2025 for its next‑generation Clarity® algorithm, which detects electrographic seizures in pre‑term and older newborns. The approval makes the Ceribell System the first and only AI‑powered point‑of‑care electroencephalography (EEG) platform cleared to monitor and detect seizures across all ages, from pre‑term neonates through adults.
The clearance was backed by EEG data from more than 700 patients, the largest validation dataset ever used for a neonatal seizure detection system. Ceribell had previously received 510(k) clearance for a neonatal‑optimized headcap, but the new approval extends the platform’s capabilities to the full spectrum of patients, positioning it as a comprehensive solution for both neonatal intensive care units (NICUs) and adult care settings.
By adding the neonatal population, Ceribell expands its total addressable market by an estimated $400 million, complementing its existing $2 billion adult seizure monitoring market. The move also strengthens the company’s competitive advantage as the only AI‑powered platform cleared for all ages, potentially accelerating adoption in NICUs where up to 90% of seizures go undetected without EEG monitoring.
Financially, Ceribell reported Q3 2025 revenue of $22.6 million, a 31% year‑over‑year increase from $17.5 million in Q3 2024, and a gross margin of 88% versus 87% in the prior year. Management has raised full‑year 2025 revenue guidance to $87 million–$89 million, reflecting confidence in continued growth across its product lines.
CEO Jane Chao emphasized the clinical importance of the clearance, stating, “Seizures are the most common neurological emergency in newborns, and protecting these fragile brains is essential to their long‑term development and well‑being.” CFO Scott Blumberg highlighted the company’s margin discipline, noting that it expects to maintain mid‑80% gross margins into 2026 despite ongoing cost pressures.
Ceribell acknowledges headwinds from rising China tariffs, which could compress margins, but the company plans to shift manufacturing to Vietnam to mitigate cost impacts. This strategic move is intended to preserve profitability while scaling production to meet the expanded market demand.
Investors have responded positively to the FDA clearance, reflecting confidence in Ceribell’s growth prospects and its position as a leader in AI‑powered EEG technology.
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