Ceribell Secures CMS New Technology Add-On Payment (NTAP) for Breakthrough Point-of-Care Delirium Monitor System

Rhea-AI Summary

Ceribell (Nasdaq: CBLL) announced that the U.S. Centers for Medicare & Medicaid Services has granted a New Technology Add-on Payment (NTAP) of up to $2,171 per eligible Medicare inpatient case for use of the Ceribell Delirium Monitor System, effective October 1, 2026.

The NTAP follows the system’s December 2025 FDA 510(k) clearance as the first and only FDA-cleared device to aid in delirium screening and monitoring. Built on Ceribell’s existing point-of-care EEG technology for detecting nonconvulsive seizures and electrographic status epilepticus, the unified platform now supports both seizure and delirium monitoring in a single bedside system for critically ill patients.

Positive

• NTAP reimbursement up to $2,171 per eligible Medicare inpatient case starting October 1, 2026
• First and only FDA-cleared device aiding delirium screening and monitoring as of December 2025
• Unified seizure and delirium platform expands coverage for critically ill patients on point-of-care EEG

Negative

• None.

News Explained

The NTAP is a Medicare hospital-inpatient add-on under the IPPS, making the disclosed economic change a case-based reimbursement pathway for eligible use of the system beginning October 1, 2026.

Market Context

CBLL has an active S-3 shelf dated 2025-11-04, with 0 reported uses and effectiveness listed as fals...

Analysis

CBLL has an active S-3 shelf dated 2025-11-04, with 0 reported uses and effectiveness listed as false. The reimbursement decision adds coverage, while recent insider activity was categorized as Net Selling.

Key Figures

NTAP payment: $2,171 per eligible Medicare patient case FDA clearance: 510(k) Payment effective date: October 1, 2026

3 metrics

NTAP payment $2,171 per eligible Medicare patient case Ceribell Delirium Monitor System

FDA clearance 510(k) Delirium Monitor System clearance in December 2025

Payment effective date October 1, 2026 NTAP add-on payment

Historical Context

5 past events · Latest: Jul 20 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 20	Earnings scheduling	Neutral	-2.9%	Announcement of second-quarter results date and conference call logistics
Jun 08	Clinical publication	Negative	-0.6%	Study linked higher AI-detected seizure burden with severe disability or death
May 20	Conference participation	Neutral	+3.5%	Management scheduled a presentation at the William Blair growth stock conference
May 11	Quarterly earnings	Negative	-16.5%	First-quarter results included a net loss despite revenue growth and raised guidance
Apr 29	Conference participation	Neutral	+4.7%	Management scheduled a fireside chat at the Bank of America health care conference

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Historical reactions were mixed, including a -16.5% move after first-quarter results and positive moves after conference notices.

Key Terms

ntap, 510(k), electroencephalogram, electrographic status epilepticus

4 terms

ntap regulatory

"CMS has granted a New Technology Add-on Payment (NTAP)"

NTAP is a stock exchange ticker symbol — a short code used to identify a particular company’s publicly traded shares on an exchange. For investors it matters because the ticker is the quick identifier used to look up real-time prices, trade the stock, check ownership and find news or filings; think of it like a vehicle’s license plate that instantly points you to everything specific about that car in traffic.

510(k) regulatory

"FDA 510(k) clearance of Ceribell’s proprietary Delirium Monitor System"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

electroencephalogram medical

"continuously analyzes automated electroencephalogram (EEG) segments"

An electroencephalogram (EEG) is a medical test that records the brain’s electrical activity through sensors placed on the scalp, producing a visual trace much like an audio recording of brain waves. For investors, EEGs matter because they are standard clinical tools and trial endpoints for neurological drugs and devices, so EEG results can influence a company’s regulatory progress, market potential, and valuation by showing objective signs of treatment effect or diagnostic capability.

electrographic status epilepticus medical

"detecting nonconvulsive seizures and electrographic status epilepticus (ESE)"

A prolonged state of continuous seizure activity detected on an electroencephalogram (EEG) without obvious convulsions, where the brain shows ongoing abnormal electrical discharges. It matters to investors because it is a serious safety and efficacy endpoint in neurological drug and device development, can trigger regulatory action or trial pauses, and may affect clinical trial outcomes, approval timelines, and potential liability in healthcare products.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Incremental NTAP Reimbursement Stands to Broaden Access to First-of-Its-Kind Dual Seizure and Delirium Monitoring Platform

SUNNYVALE, Calif., Aug. 03, 2026 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell” or the “Company”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for up to $2,171 per eligible Medicare patient case utilizing the Ceribell Delirium Monitor System.¹

This follows the December 2025 U.S. Food and Drug Administration (FDA) 510(k) clearance of Ceribell’s proprietary Delirium Monitor System,² establishing it as the first and only FDA-cleared device used to aid in delirium screening and monitoring.

The system continuously analyzes automated electroencephalogram (EEG) segments, notifying clinicians upon detecting patterns associated with delirium, to support rapid and objective treatment decision-making.

With the addition of the NTAP for delirium monitoring, the Ceribell Point-of-Care EEG platform now offers expanded coverage for critically ill patients. Built on Ceribell’s existing FDA-cleared technology for detecting nonconvulsive seizures and electrographic status epilepticus (ESE), this unified platform seamlessly integrates both seizure and delirium monitoring into a single system. By tracking multiple neurological vital signs simultaneously at the bedside, Ceribell equips providers with comprehensive diagnostic insights to manage co-occurring brain risks without requiring separate devices.

CMS established the NTAP process to identify and ensure adequate payment for certain new medical services and technologies under the Medicare Hospital Inpatient Prospective Payment System (IPPS). The add-on payment will take effect on Oct. 1, 2026.

“We believe that CMS’ NTAP decision underscores the profound clinical necessity and transformative value of our point-of-care technology for critically ill patients,” said Jane Chao, Ph.D., co-founder and CEO of Ceribell. “The add-on payment will help facilitate widespread commercial access to this vital innovation for a highly vulnerable patient population. This marks a pivotal milestone in our strategic mission to establish EEG as an essential new vital sign for better brain care.”

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding the facilitation of patient access to the Ceribell System and the availability of reimbursement for the Ceribell System, are forward-looking statements. 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 as of the date of this press release and involve risks and uncertainties that could cause actual results to differ materially from those described. Such risks and uncertainties, including but not limited to those related to regulatory approvals, clinical use and adoption, clinical outcomes, market acceptance, competition, and other factors, are described under the “Risk Factors” sections of the Company’s 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://www.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 applicable 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 http://www.ceribell.com or follow the company on LinkedIn.

Investor Contact
Brian Johnston or Caylene Parrish
Gilmartin Group
Investors@ceribell.com

Media Contact
Brian Price
Press@ceribell.com

^{_________________________________
1} https://public-inspection.federalregister.gov/2026-15833.pdf
² FDA 510k Clearance Letter K251936

FAQ

What did CMS approve for Ceribell (CBLL) on October 1, 2026?

CMS approved a New Technology Add-on Payment for Ceribell’s Delirium Monitor System, effective October 1, 2026. According to Ceribell, hospitals may receive up to $2,171 per eligible Medicare inpatient case using the system.

How much is the CMS NTAP reimbursement for Ceribell (CBLL) Delirium Monitor System?

The CMS New Technology Add-on Payment is up to $2,171 per eligible Medicare case. According to Ceribell, this incremental reimbursement is intended to support hospital adoption of its point-of-care delirium monitoring technology for Medicare inpatients.

What is the Ceribell (CBLL) Delirium Monitor System used for?

The Ceribell Delirium Monitor System aids in delirium screening and monitoring in critically ill patients. According to Ceribell, it continuously analyzes EEG segments and alerts clinicians to patterns associated with delirium to support rapid, objective treatment decisions at the bedside.

Is Ceribell’s (CBLL) Delirium Monitor the first FDA-cleared device for delirium monitoring?

Yes. According to Ceribell, its Delirium Monitor System received FDA 510(k) clearance in December 2025 as the first and only FDA-cleared device used to aid delirium screening and monitoring in clinical settings.

How does the NTAP decision affect Ceribell’s (CBLL) point-of-care EEG platform?

The NTAP adds reimbursement for delirium monitoring on Ceribell’s point-of-care EEG platform. According to Ceribell, the unified system now integrates nonconvulsive seizure, electrographic status epilepticus, and delirium monitoring into a single bedside platform for critically ill patients.

What patient population is targeted by Ceribell’s (CBLL) NTAP-supported Delirium Monitor System?

The system targets critically ill Medicare inpatients at risk of delirium and seizures. According to Ceribell, bedside EEG-based monitoring offers clinicians comprehensive neurological insights to manage co-occurring brain risks without relying on multiple separate devices.