CBLL Gets FDA Consent for One-of-a-Kind Delirium Monitoring Solution

CeriBell Inc. CBLL recently announced that the FDA has given 510(k) clearance for its latest delirium monitoring solution, making it the one and only FDA-cleared solution for continuous tracking of delirium. This milestone confirms the Ceribell System as an AI-driven brain-monitoring platform, extending its clinical efficacy by giving doctors useful information to detect risk for both seizures and delirium in more critically ill patients.

Delirium is a major unaddressed critical condition, as current screening relies on occasional bedside assessments, depending on personal judgment, which can vary from one clinician to another. CBLL’s FDA-approved Delirium Monitoring Solution continuously monitors brain activity through electroencephalography (EEG) and notifies clinicians when it sees patterns that suggest delirium. Stanford anesthesiology expert Dr. Juliana Barr says that the technology can potentially improve delirium detection rates, allow faster treatment and reduce the cost burden on both families and hospitals due to missed or delayed diagnoses.

Management noted that the FDA clearance enables CBLL to enlarge its footprint in delirium care by offering the first continuous, objective EEG technology to support doctors with early detection of delirium in critically ill patients. Further, the company will soon wrap up its launch plans and will deliver this breakthrough AI-powered neuro-monitoring technology to patients, making EEG a system-wide standard for brain care.

Likely Trend of CBLL Stock Following the News

Shares of CBLL have lost 3.8% since the announcement on Wednesday. Year to date, shares of CeriBell have declined 21.1% against the industry’s 1.1% growth and the S&P 500’s 19.5% rise.

In the long run, the FDA clearance gives CeriBell a competitive advantage as well as supports its long-term mission of making continuous AI-based EEG technology a standard, essential tool in detecting seizure and delirium — a condition that affects up to 31% of ICU patients, 80% of ventilated patients and increases mortality rate by 10%, with longer hospital stays and higher post-ICU dementia risk. CBLL’s ability to deliver continuous AI-driven monitoring in serious neurological conditions reinforces its strategic vision of making EEG a new vital sign.

CBLL currently has a market capitalization of $748.59 million.

More on the Delirium Monitoring Solution

CBLL’s newly cleared point-of-care EEG system addresses key gaps in delirium, seizure and electrographic status epilepticus care by routine EEG-based screening that provides clinicians with real-time neurological insights to support earlier detection, reduce clinical variability and improve bedside decision-making.

CBLL’s delirium algorithm was tested on 225 critically ill adults, showing real-world reliability. The FDA clearance builds on the technology’s earlier Breakthrough Device Designation and the company has also applied for a New Technology Add-on Payment (NTAP) to the Centers for Medicare and Medicaid Services (CMS) to support hospitals with reimbursement benefits.

Studies show that nearly 48% of ICU patients undergoing seizures develop peri-ictal delirium, and 42% of older ICU patients with delirium show epileptiform discharges. Hence, by innovating an advanced seizure and delirium monitoring tool, CBLL enables thorough diagnosis of patient brain health and guides treatments that may improve outcomes.

CeriBell, Inc. Price

CeriBell, Inc. price | CeriBell, Inc. Quote

CBLL’s Zacks Rank & Key Picks

Currently, CBLL carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Phibro Animal Health PAHC, AtriCure ATRC and Boston Scientific BSX.

Phibro Animal Health, sporting a Zacks Rank #1 (Strong Buy) at present, reported third-quarter 2025 adjusted earnings per share (EPS) of 73 cents, which surpassed the Zacks Consensus Estimate by 23.73%. Revenues of $363.9 million beat the Zacks Consensus Estimate by 2.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.

PAHC has an estimated long-term earnings growth rate of 12.8% compared with the industry’s 13.2% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 20.77%.

AtriCure, currently carrying a Zacks Rank #2 (Buy), reported a third-quarter 2025 adjusted loss per share of 1 cent, narrower than the Zacks Consensus Estimate by 90.91%. Revenues of $134.3 million beat the Zacks Consensus Estimate by 2.09%.

ATRC has an estimated earnings growth rate of 64.2% for 2025 compared with the industry’s 11.5% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 67.06%.

Boston Scientific, currently carrying a Zacks Rank #2, reported a third-quarter 2025 adjusted EPS of 75 cents, which surpassed the Zacks Consensus Estimate by 5.63%. Revenues of $5.07 billion beat the Zacks Consensus Estimate by 1.9%.

BSX has an estimated long-term earnings growth rate of 16.4% compared with the industry’s 13.2% growth. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 7.36%.

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