Ceribell Receives FDA 510(k) Clearance for First-of-its-Kind Delirium Monitoring Solution

Rhea-AI Summary

Ceribell (Nasdaq: CBLL) announced FDA 510(k) clearance for its delirium monitoring solution on Dec 9, 2025, the first FDA-cleared device for continuous delirium screening at the bedside. The solution extends the Ceribell System to simultaneously support continuous seizure, electrographic status epilepticus (ESE), and delirium monitoring.

The delirium algorithm was validated in prospective studies of 225 adults in critical care. Ceribell has submitted a NTAP application to CMS to seek additional reimbursement for the new indication.

Positive

• FDA 510(k) clearance for delirium monitoring (Dec 9, 2025)
• Algorithm validated in 225 adult critical-care study participants
• System supports simultaneous seizure and delirium continuous monitoring
• Submitted NTAP application to CMS for reimbursement consideration

Negative

• NTAP reimbursement decision pending, creating near-term adoption uncertainty

Key Figures

Validation sample size 225 adults Prospective critical-care studies for delirium algorithm

Minimum age 22 years Age threshold for adults in validation studies

ICU delirium prevalence ~31% Share of ICU patients affected by delirium

Ventilated patients delirium up to 80% Delirium rate in mechanically ventilated ICU patients

Mortality increase 10% Higher 6‑month mortality risk per day of delirium

Post‑ICU dementia risk 60% higher Dementia risk in ICU patients with prior delirium

Peri‑ictal delirium rate ~48% ICU seizure patients experiencing peri‑ictal delirium

Epileptiform discharges 42% Older ICU patients with delirium showing epileptiform discharges

Market Reality Check

$20.18 Last Close

Volume Volume 669,878 is 36% above the 20-day average of 493,081. normal

Technical Price $20.22 is trading above the 200-day MA of $15.7, showing a pre-existing uptrend.

Peers on Argus

CBLL gained 2.54% while key device peers were mixed: BFLY (-2.79%), RXST (-1.1%), SMLR (+4.99%), SRDX (+0.26%), TMCI (-5.09%). This suggests a stock-specific response rather than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 24	Regulatory clearance	Positive	+4.9%	FDA 510(k) clearance for Clarity algorithm across all ages.
Nov 19	Conference participation	Neutral	-0.1%	CEO presentation at Piper Sandler healthcare conference.
Nov 06	Conference participation	Neutral	+3.6%	CFO fireside chat at a Canaccord Genuity MedTech forum.
Nov 04	Earnings report	Positive	-3.7%	Q3 2025 results with 31% revenue growth and raised guidance.
Oct 21	Earnings scheduling	Neutral	+7.0%	Announcement of Q3 2025 earnings release and conference call.

Pattern Detected

Recent FDA clearances and corporate events have usually led to price gains, but the strong Q3 earnings update saw a negative reaction, indicating occasional divergence on financial results.

Recent Company History

Over the past few months, Ceribell reported strong growth and multiple milestones. Q3 2025 revenue reached $22.6M with guidance raised to $87M–$89M, though shares fell 3.7% after earnings. Subsequent conference appearances had modest positive or flat reactions. On Nov 24, FDA 510(k) clearance for the Clarity algorithm across all ages drove a 4.91% gain, showing the market’s focus on regulatory catalysts. Today’s new FDA 510(k) clearance for delirium monitoring extends that regulatory momentum for the Ceribell System.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-11-04

$300,000,000 registered capacity

On Nov 4, 2025, Ceribell filed an S-3 universal shelf registration to offer up to $300,000,000 of securities, enabling flexible future capital raises through various instruments as detailed in prospectus supplements.

Market Pulse Summary

This announcement details FDA 510(k) clearance for Ceribell’s delirium monitoring solution, extending its AI‑based EEG platform to critically ill adults validated in a cohort of 225 patients. It follows a prior seizure‑detection clearance that previously drove a 4.91% move, reinforcing a pattern of regulatory progress. Investors may track how this indication affects adoption alongside earlier Q3 2025 results, where revenue reached $22.6M, and consider the role of the $300,000,000 shelf registration in funding future growth.

Key Terms

electroencephalography (EEG) medical

"point-of-care electroencephalography (EEG) system to address long unmet need"

Electroencephalography (EEG) records the brain’s electrical activity through sensors placed on the scalp, capturing patterns of brain waves much like a seismograph records tremors. Investors care because EEG data are used to show how neurological drugs, devices and diagnostic tools affect the brain, influencing clinical trial results, regulatory approvals and market adoption that drive a company’s revenue and development timeline.

EEG medical

"continuously analyzes EEG segments and notifies clinicians when patterns"

An EEG (electroencephalogram) is a medical test that records the brain’s electrical activity through small sensors placed on the scalp, similar to reading patterns of a city’s traffic to understand flow and disruptions. For investors, EEGs matter because they are central to diagnosing and monitoring neurological conditions, validating new brain-related treatments or devices, and supporting regulatory approvals and reimbursement — factors that drive market demand and revenue potential. Changes in EEG technology, usage or guidelines can affect companies that make the equipment, offer related services, or develop therapies tied to brain signals.

electrographic status epilepticus (ESE) medical

"support continuous seizure, electrographic status epilepticus (ESE), and delirium"

Electrographic status epilepticus (ESE) is a prolonged period of seizure activity that is visible only on an electroencephalogram (EEG) rather than through obvious physical symptoms. It matters to investors because ESE often requires urgent, intensive treatment, can worsen patient outcomes, and drives demand for monitoring equipment, anti-seizure drugs, and critical-care resources; think of it like a silent alarm on a hospital monitor that triggers costly, high-stakes responses.

510(k) clearance regulatory

"U.S. Food and Drug Administration (FDA) has granted 510(k) clearance"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

Breakthrough Device Designation regulatory

"FDA clearance follows Ceribell’s initial receipt of a Breakthrough Device Designation"

A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.

New Technology Add-on Payment (NTAP) financial

"has submitted a New Technology Add-on Payment (NTAP) application"

A new technology add-on payment (NTAP) is a temporary extra reimbursement from Medicare to hospitals that helps cover the higher initial costs of using an eligible, recently introduced medical device, drug or test. Think of it as a short-term subsidy that lowers the financial hurdle for hospitals to try a promising new tool; for investors it signals faster adoption, clearer early cash flow prospects, and improved reimbursement prospects for the technology maker.

Centers for Medicare and Medicaid Services (CMS) regulatory

"NTAP application to the Centers for Medicare and Medicaid Services (CMS)"

The Centers for Medicare & Medicaid Services (CMS) is a U.S. federal agency that runs the country’s major public health insurance programs and sets rules for how providers get paid and how medical products are covered. Investors care because CMS decisions on coverage, payment rates, and rules can change how much revenue healthcare companies earn—think of CMS like a giant client or regulator whose pricing and coverage choices can make or break a product’s market.

epileptiform discharges medical

"another study finding epileptiform discharges in 42% of older ICU patients"

Epileptiform discharges are brief, abnormal bursts of brain electrical activity seen on an electroencephalogram (EEG) that indicate a brain is prone to producing seizures. For investors, their presence matters because they can signal higher clinical risk or change how a condition is treated, which may affect patient enrollment in trials, regulatory decisions, drug labeling, market size and healthcare costs—like a dashboard warning light that signals increased risk for future problems.

AI-generated analysis. Not financial advice.

Novel technology paves the way for use of the company's industry-leading point-of-care electroencephalography (EEG) system to address long unmet need in delirium monitoring

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, professor emerita of anesthesiology, perioperative and pain medicine at Stanford University School of Medicine. “Current detection methods rely on intermittent, labor-intensive bedside assessments that are subject to human variability. Ceribell offers a reliable continuous monitoring solution that has the potential to improve delirium detection rates and management, and reduce the high costs associated with missed or delayed diagnoses.”

Ceribell’s delirium monitoring solution continuously analyzes EEG segments and notifies clinicians when patterns associated with delirium are detected, supporting more timely, reliable evaluation, and continuous monitoring of delirium. This will allow the Ceribell System to simultaneously support continuous seizure, electrographic status epilepticus (ESE), and delirium monitoring at the bedside.

Ceribell’s delirium algorithm was validated using EEG data and clinical assessments collected through rigorous prospective studies involving 225 adults aged 22 years or older in critical care environments. This validation underscores the algorithm’s reliability and real-world utility for continuous delirium monitoring in the critical care setting. FDA clearance follows Ceribell’s initial receipt of a Breakthrough Device Designation for delirium monitoring in 2022. Ceribell has submitted a New Technology Add-on Payment (NTAP) application to the Centers for Medicare and Medicaid Services (CMS) for this new indication.

Delirium is a common and serious neurological condition affecting ~31% of ICU patients, and up to 80% of those who are mechanically ventilated.^2,3 It is associated with poor clinical outcomes, including a 10% higher 6-month mortality risk for every day delirium is experienced,⁴ as well as longer hospital stays and increased hospitalization costs.⁵ The risk of post-ICU dementia is 60% higher in discharged ICU patients who have had delirium, compared to those who have not had delirium in the ICU.⁶ Current Society of Critical Care Medicine guidelines recommend regular delirium assessment using validated tools,⁷ underscoring the need for early and accurate detection. Nonetheless, delirium - particularly hypoactive delirium⁸ - often goes unrecognized due to challenges in clinical assessment and the lack of objective, continuous monitoring tools. Ceribell’s delirium monitoring solution addresses this gap by providing real-time, objective neurological insights at the bedside.

Moreover, studies have demonstrated a relationship between seizure and delirium, with one study showing that ~48% of patients experiencing seizures in the ICU had peri-ictal delirium,⁹ and another study finding epileptiform discharges in 42% of older ICU patients with delirium.¹⁰ By combining advanced seizure and delirium monitoring capabilities, the Ceribell System will help clinicians better understand patient presentation and support more timely clinical decision making.

“Delirium has been under recognized and under treated in critically ill patients for far too long, despite its strong association with poor outcomes,” said Jane Chao, Ph.D., co-founder and CEO of Ceribell. “With this FDA clearance, Ceribell is proud to expand EEG technology into delirium care, bringing the first objective, continuous monitoring solution to clinicians who urgently need better tools to support these vulnerable patients. We expect to finalize our go-to-market strategy in the near future, and look forward to leveraging our existing commercial footprint and reputation as the category leader in AI-based neuro monitoring to bring this transformational technology to patients in need. This is another big step towards our mission of making EEG a new vital sign for better brain care.”

References

1. FDA 510k Clearance Letter K251936
2. Krewulak, K.D., et al. (2018) Crit Care Med 46(12):p 2029-2035
3. Girard, T.D., et al. (2008). Crit Care 12 Suppl 3(Suppl 3):S3
4. Ely, E.W., et al. (2004) JAMA 291(14):1753-62
5. Taha, A., et al. (2023) Medicine 102(2):e32652
6. Wang, S. et al. (2024) Alzheimer's & Dementia, 20(1), 278-287.
7. Devlin, J.W., et al. (2018) Crit Care Med 46(9):e825-e873
8. de Lourdes Ramírez Echeverría, M., et al. (2022) Delirium. In StatPearls [Internet]
9. Frei, A.I., et al. (2024) Journal of Neurology, 271(1), pp.231-240
10. Sambin, S., et al. (2019) Frontiers in neurology, 10, p.263.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other statements that are not statements of historical fact. Forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope,” and other words of similar meaning. These statements are based on management’s current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those described. Such risks and uncertainties, including those related to regulatory approvals, clinical use and adoption, market acceptance, competition, and other factors, are described under the “Risk Factors” sections of our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other reports filed with the U.S. Securities and Exchange Commission (“SEC”). These filings are available on the SEC’s website at https://sec.gov/ and on Ceribell’s website at https://investors.ceribell.com/. Ceribell undertakes no obligation to update any forward-looking statements as a result of new information, future events, or otherwise, except as required by law.

About CeriBell, Inc.
Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. Ceribell has developed the Ceribell System, a novel, point-of-care electroencephalography (“EEG”) platform specifically designed to address the unmet needs of patients in the acute care setting. By combining proprietary, highly portable, and rapidly deployable hardware with sophisticated artificial intelligence (“AI”)-powered algorithms, the Ceribell System enables rapid diagnosis and continuous monitoring of patients with neurological conditions. The Ceribell System is FDA-cleared for detecting seizure and delirium for use in intensive care units and emergency rooms across the U.S. Ceribell is headquartered in Sunnyvale, California. For more information, please visit www.ceribell.com or follow the company on LinkedIn.

Investor Contact
Brian Johnston or Laine Morgan
Gilmartin Group
Investors@ceribell.com

Media Contact
Brian Price
Press@ceribell.com

FAQ

What did Ceribell (CBLL) announce on December 9, 2025?

Ceribell announced FDA 510(k) clearance for its continuous delirium monitoring solution, expanding its Ceribell System indications.

How was Ceribell's delirium algorithm validated for CBLL's new indication?

The algorithm was validated using EEG data and clinical assessments from a prospective study of 225 adults in critical care.

Will the Ceribell System monitor seizures and delirium simultaneously (CBLL)?

Yes. The clearance allows the Ceribell System to support continuous monitoring for seizures, ESE, and delirium at the bedside.

Did Ceribell (CBLL) seek reimbursement for its delirium monitoring solution?

Yes. Ceribell has submitted a New Technology Add-on Payment (NTAP) application to CMS for the new indication.

Why is continuous delirium monitoring important for ICU patients (CBLL)?

Delirium affects ~31% of ICU patients (up to 80% of ventilated patients) and is linked to higher mortality risk, longer stays, and increased long-term cognitive decline.