Ceribell Receives FDA Breakthrough Device Designation for LVO Stroke Detection and Monitoring Solution

Rhea-AI Summary

Ceribell (Nasdaq: CBLL) announced that the U.S. Food and Drug Administration granted Breakthrough Device Designation on January 5, 2026 for its Large Vessel Occlusion (LVO) stroke detection and monitoring solution for hospital patients.

The first-in-class monitor uses Ceribell’s existing point-of-care EEG hardware combined with an AI algorithm to interpret EEG signals for early LVO detection, and builds on recent 510(k) clearances for a neonatal seizure algorithm (Nov 2025) and a delirium screening solution (Dec 2025). The designation is supported by validation from prospective, multi-center studies using EEG data and clinical assessments and targets timely detection of in-hospital strokes, a population that represents up to 17% of U.S. strokes.

Positive

• FDA Breakthrough Device Designation granted on Jan 5, 2026
• Uses existing point-of-care EEG hardware with AI algorithm
• Supported by prospective, multi-center validation studies
• Builds on recent 510(k) clearances in Nov and Dec 2025
• Targets in-hospital strokes representing up to 17% of U.S. strokes

Negative

• None.

Key Figures

Annual strokes (US) 800,000 strokes Approximate annual stroke incidence cited for the United States

Post-stroke dependence 62% Share of post-stroke dependence attributed to LVO strokes

Post-stroke mortalities 96% Share of post-stroke deaths attributed to LVO strokes

In-hospital stroke rate 17% Proportion of total strokes that are in-hospital-onset

Mortality risk increase 3x higher In-hospital stroke mortality rate vs community-onset stroke

Discharge likelihood Half as likely In-hospital stroke patients discharged home vs community-onset

Disability-free life gain 1 week per minute Every minute saved in LVO treatment linked to a week of disability-free life

Recent 510(k) dates Nov 2025 & Dec 2025 Clearances for Clarity® neonatal seizures and delirium monitoring

Market Reality Check

$23.07 Last Close

Volume Volume 283,383 is below the 20-day average of 565,501 (relative volume 0.5x) ahead of this news. low

Technical Shares at $21.30 are trading above the 200-day MA of $15.56, while still 20.61% below the 52-week high.

Peers on Argus 1 Up

Peers show mixed moves: BFLY (-3.35%), RXST (-1.98%), SMLR (+13.76%), SRDX (+0.26%), TMCI (+1.63%). Only SMLR appears in momentum scans, suggesting today’s setup is more stock-specific than a broad medical devices move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 30	Conference participation	Neutral	+1.0%	Announcement of J.P. Morgan Healthcare Conference presentation and webcast details.
Dec 09	Regulatory clearance	Positive	+5.0%	FDA 510(k) clearance for first-of-its-kind delirium monitoring solution.
Nov 24	Regulatory clearance	Positive	+4.9%	FDA 510(k) clearance for Clarity algorithm use in neonates and all ages.
Nov 19	Conference participation	Neutral	-0.1%	Participation announcement for Piper Sandler healthcare conference with webcast.
Nov 06	Conference participation	Neutral	+3.6%	Canaccord Genuity MedTech forum fireside chat participation and webcast access.

Pattern Detected

Recent FDA clearance news (neonatal Clarity and delirium monitoring) both saw positive next-day reactions, suggesting investors have previously rewarded regulatory milestones.

Recent Company History

Over the past few months, Ceribell reported several notable catalysts. In Q4 2025, it secured FDA 510(k) clearances for its Clarity® algorithm in neonates and for a delirium monitoring solution, each followed by ~5% positive price reactions. The company also maintained regular visibility through conference presentations in November–December 2025, which had modest price impacts. Today’s FDA Breakthrough Device Designation extends the same EEG platform into LVO stroke detection, consistent with this trajectory of expanding indications.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-11-04

$300,000,000 registered capacity

An effective S-3 shelf filed on Nov 4, 2025 allows Ceribell to register up to $300,000,000 of various securities for potential future offerings, providing flexibility to raise capital over time via underwriters, agents, or direct sales.

Market Pulse Summary

This announcement highlights an FDA Breakthrough Device Designation for Ceribell’s EEG-based LVO stroke detection monitor, extending its platform beyond prior 510(k) clearances in neonates and delirium from November and December 2025. The news underscores the clinical burden of LVO strokes and in-hospital strokes, where delays worsen outcomes. Investors may watch upcoming validation data, regulatory steps, and how the company prioritizes this indication alongside other cleared uses.

Key Terms

breakthrough device designation regulatory

"FDA has granted Breakthrough Device Designation for its Large Vessel Occlusion"

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.

electroencephalography (eeg) medical

"only point-of-care electroencephalography (EEG) technology to aid in detection"

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.

large vessel occlusion (lvo) medical

"to aid in detection and monitoring of Large Vessel Occlusion (LVO) stroke"

A large vessel occlusion (LVO) is a blockage in one of the brain’s major arteries that causes a severe type of stroke, like a major highway suddenly closed to all traffic. It matters to investors because LVOs require urgent, often specialized treatments that drive demand for emergency devices, drugs and hospital services, influence clinical trial outcomes and regulatory approvals, and can meaningfully affect healthcare spending and company revenues.

ai-based algorithm technical

"applies an AI-based algorithm to interpret EEG signals for early detection"

An AI-based algorithm is a computer program that uses artificial intelligence to analyze large amounts of data, learn patterns, and make predictions or decisions without being given step-by-step instructions. Investors care because these tools can speed up research, reveal trading opportunities or risks, and automate choices—like a smart assistant that scans thousands of reports and flags what matters—affecting a company’s costs, competitive edge and reliability of forecasts.

510(k) clearances regulatory

"building on recent FDA 510(k) clearances for its next-generation Clarity"

A 510(k) clearance is a U.S. Food and Drug Administration (FDA) decision that allows a medical device to be marketed because it is shown to be similar enough to an already approved device. For investors, a 510(k) is a regulatory green light that can shorten time to sales and reduce development costs—like getting permission to sell a new model that works much like an established product—but it is not the same as a full safety or effectiveness guarantee.

ischemic stroke medical

"compared to non-LVO ischemic stroke, contributing to ~62% of post-stroke"

An ischemic stroke occurs when a blood vessel supplying the brain is blocked, cutting off oxygen and nutrients to part of the brain — like a kinked garden hose that stops water flow. It matters to investors because its incidence and outcomes drive demand for drugs, emergency devices, diagnostic tools, rehabilitation services and clinical trials; changes in treatment effectiveness, approvals or costs can materially affect healthcare companies and insurers.

endovascular therapy medical

"Meretoja, A. et al. (2017). Endovascular therapy for ischemic stroke"

Endovascular therapy uses thin tubes and tiny tools threaded through blood vessels to diagnose or fix problems—clearing blockages, sealing weak spots, or removing clots—without open surgery; think of repairing pipes from the inside. It matters to investors because it creates demand for specialized medical devices and disposable supplies, affects hospital procedure volumes and costs, and influences adoption, reimbursement and revenue trends across device makers, hospitals and insurers.

multi-center studies technical

"validated through rigorous, prospective, multi-center studies using EEG data"

Multi-center studies are clinical or scientific trials carried out at several hospitals, clinics, or research sites rather than a single location. Like testing a recipe in many kitchens to see if it works for different cooks and equipment, these studies give investors a better sense of whether results are reliable, generalizable, and likely to persuade regulators and doctors — factors that can affect a treatment’s market potential and company value.

AI-generated analysis. Not financial advice.

Clearance would position the Ceribell System as the first and only point-of-care electroencephalography (EEG) technology to aid in detection and monitoring of Large Vessel Occlusion (LVO) stroke in the hospital setting

SUNNYVALE, Calif., Jan. 05, 2026 (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 Breakthrough Device Designation for its Large Vessel Occlusion (LVO) stroke detection monitor for patients in the hospital setting. This first-in-class LVO stroke detection monitor uses Ceribell’s existing hardware and applies an AI-based algorithm to interpret EEG signals for early detection of LVO stroke.

The Breakthrough Device Designation for LVO Stroke represents the latest achievement in Ceribell’s continued efforts to extend its point-of-care EEG brain monitoring technology to additional indications, building on recent FDA 510(k) clearances for its next-generation Clarity® algorithm to detect electrographic seizures in neonates (November 2025) and its proprietary delirium screening and monitoring solution (December 2025).

Nearly 800,000 strokes occur annually in the U.S.¹ In particular, LVO strokes are medical emergencies and have disproportionately higher morbidity and mortality compared to non-LVO ischemic stroke, contributing to ~62% of post-stroke dependence and ~96% of post-stroke mortalities.² Timely detection and access to treatment of LVO stroke can result in tremendous health benefits over patients’ lifetimes, with every minute saved associated with a week of disability-free life.³

Unlike community-onset stroke, which occurs outside the hospital and often triggers immediate emergency response, in-hospital stroke affects patients who are already admitted. Scientific literature shows that stroke detection and treatment in hospitalized patients are often significantly delayed compared to strokes occurring outside of hospitals.^4,5,6 This leads to worse outcomes, as patients face about three times higher rates of mortality, and are half as likely to be discharged home compared to community-onset stroke, even after adjusting for clinical characteristics and comorbidities in hospitalized patients.⁷ Out of 800,000 stroke patients, up to 17% are in-hospital-onset stroke.^4,5

Dr. Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS, Clinical Professor of Neurology and Neurosurgery, notes that: “In-hospital strokes frequently occur in units that aren’t specialized in neurology, where bedside teams may not have sufficient training or tools to detect subtle neurological changes concerning a stroke. Many of these patients are recovering from surgery, intubated, ventilated, or on medications that complicate their assessment, making it incredibly difficult to spot the early signs of a stroke. A tool that continuously monitors brain function and alerts the care team the moment something is wrong would allow us to intervene sooner and facilitate achieving better outcomes for patients.”  

The Breakthrough Device Designation recognizes the potential of Ceribell’s LVO stroke detection monitor to enable timely and accurate LVO detection compared to the current standard-of-care, supported by validation through rigorous, prospective, multi-center studies using EEG data and clinical assessments. “Stroke is a devastating condition, but one where quick access to treatment can make a lifetime of a difference,” said Jane Chao, Ph.D., co-founder and CEO of Ceribell. “At a time when minutes matter, patients with in-hospital stroke often experience hours of delay. Ceribell is proud that this FDA Breakthrough Device Designation recognizes the potential of the Ceribell System to provide accurate and timely detection of LVO stroke for this vulnerable patient population.”

The LVO Breakthrough Device designation is another critical milestone that further reinforces Ceribell’s mission to make EEG a new vital sign for better brain care.

References
¹ Martin, S. S., et al. (2025). 2025 Heart disease and stroke statistics: A report of US and global data from the American Heart Association. Circulation, 151(8), e41–e660. https://doi.org/10.1161/CIR.0000000000001303

 ² Malhotra, et al. (2017). Ischemic strokes due to large-vessel occlusions contribute disproportionately to stroke-related dependence and death: A review. Frontiers in Neurology, 8, 651.https://doi.org/10.3389/fneur.2017.00651 

³ Meretoja, A. et al. (2017). Endovascular therapy for ischemic stroke: Save a minute — save a week. Neurology, 88(22), 2123–2127. https://doi.org/10.1212/WNL.0000000000003981 

⁴ Nouh, A. et al. (2022). Identifying best practices to improve evaluation and management of inhospital stroke: A scientific statement from the American Heart Association. Stroke, 53(4), 165–175. https://doi.org/10.1161/STR.0000000000000402 

⁵ Cumbler, E. (2015). In-hospital ischemic stroke. The Neurohospitalist, 5(4), 173–181. https://doi.org/10.1177/1941874415588319 

⁶ Cummings, S. et al. (2022). Delays in the identification and assessment of in-hospital stroke patients. Journal of Stroke and Cerebrovascular Diseases, 31(4), 106327. https://doi.org/10.1016/j.jstrokecerebrovasdis.2022.106327

⁷ Cumbler, E. et al. (2014). Quality of care and outcomes for inhospital ischemic stroke: Findings from the National Get With The Guidelines-Stroke. Stroke, 45(1), 231–238. https://doi.org/10.1161/STROKEAHA.113.003617  

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 use in detecting seizure and delirium 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 January 5, 2026?

Ceribell announced FDA Breakthrough Device Designation for its hospital LVO stroke detection monitor.

How does Ceribell's LVO monitor detect strokes for CBLL?

It applies an AI algorithm to Ceribell’s point-of-care EEG hardware to interpret signals for early LVO detection.

What regulatory milestones did Ceribell (CBLL) achieve before the LVO designation?

Ceribell received 510(k) clearances for a Clarity neonatal seizure algorithm in Nov 2025 and a delirium solution in Dec 2025.

Why is in-hospital LVO detection important for Ceribell (CBLL)?

In-hospital strokes face delayed recognition and represent up to 17% of U.S. strokes, with worse outcomes compared to community-onset strokes.

What evidence supported the Breakthrough designation for CBLL’s LVO monitor?

The designation is supported by validation from rigorous, prospective, multi-center studies using EEG data and clinical assessments.