NeuroPace Announces FDA Approval of ECoG Assistant™, Advancing AI-Driven Epilepsy Care

Key Terms

ecog medical

ECOG (Eastern Cooperative Oncology Group) performance status is a simple scale doctors use to rate how well a cancer patient can carry out everyday activities, ranging from fully active to bedridden. For investors, ECOG scores matter because they shape which patients can join clinical trials, influence how well a treatment appears to work, and affect regulatory decisions and the size of the potential market—think of it as a fitness score that changes who benefits from a drug and how convincing the trial results are.

ieeg medical

Intracranial electroencephalography (iEEG) is a medical recording method that places tiny sensors directly on or in the brain to measure electrical activity. Think of it as putting microphones right on a concert stage to hear individual instruments instead of listening from the audience. For investors, iEEG matters because it underpins advanced diagnostics, surgical planning, and next‑generation medical devices and brain‑computer interfaces, which can drive clinical adoption, regulatory scrutiny, and commercial opportunity.

rns system medical

A Regulatory News Service (RNS) system is an official channel that distributes company announcements, financial reports, and other market-sensitive information to regulators, exchanges, and the public. It matters to investors because it ensures timely, standardized disclosure—think of it as a public bulletin board that guarantees everyone sees important corporate news at the same time, reducing surprises and helping investors make informed decisions.

fda approval regulatory

FDA approval is the U.S. Food and Drug Administration’s formal authorization for a drug, vaccine, or medical device to be marketed and sold after reviewers determine it meets standards for safety and effectiveness. For investors it’s a pivotal milestone because it opens the door to legal, large-scale sales and can sharply boost revenue potential while reducing regulatory uncertainty—like receiving a safety certificate that lets a new bridge carry traffic and tolls.

patient data management system technical

A patient data management system is software that collects, organizes and stores medical information from hospitals, devices and clinics — like a secure, digital filing cabinet and traffic controller for health data. It matters to investors because it affects a healthcare provider’s efficiency, costs, regulatory risk and ability to launch new services: better data tools can reduce errors, speed decisions, protect patient privacy and create revenue opportunities through improved care and analytics.

cloud-based technical

Software, data or services that run on remote computers accessed over the internet instead of on a user’s own device; think of renting storage, apps and computing power in someone else’s warehouse rather than buying and maintaining the gear yourself. Investors care because cloud-based models can lower a company’s upfront costs, speed product updates, scale quickly with demand and create recurring revenue, all of which affect cash flow, growth prospects and valuation.

artificial intelligence technical

Artificial intelligence is the ability of computers and machines to perform tasks that typically require human thinking, such as understanding language, recognizing patterns, or making decisions. For investors, it matters because AI can enhance efficiency, uncover new insights, and enable smarter strategies, potentially impacting the value and performance of companies that develop or utilize this technology.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

-- First in a suite of planned NeuroPace AI tools designed to deliver deeper data insights, support clinical outcomes and further enhance efficiency of RNS therapy --

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced FDA approval of ECoG Assistant, its first AI-driven clinician-enabled feature. This milestone represents an important step in NeuroPace’s broader AI platform strategy, leveraging the world’s only long-term intracranial EEG dataset to transform how epilepsy is monitored and managed.

ECoG Assistant: Treatment Insights Simplified

ECoG Assistant is the first in a suite of planned NeuroPace AI tools designed to further support clinical decision making through deeper data insights and more efficient ECoG review. Built on years of proprietary, patient-level brain data captured through the RNS^® System, ECoG Assistant empowers clinicians to be supported in making faster, more confident treatment decisions.

The ECoG Assistant model was developed on 124,450 epileptologist labeled iEEG long-episode records, enabling it to identify ECoGs of Interest using these records. Now, from a single view, physicians can review ECoGs of Interest spanning months using the ECoG Assistant Trends Report and explore timing patterns and potential triggers using the Circadian Pattern Chart.

“ECoG Assistant represents an important advancement in how clinicians interact with iEEG data and the RNS System,” said Dr. Martha Morrell, Chief Medical Officer, NeuroPace. “By harnessing AI trained on a subset of the largest intracranial EEG dataset in the world, we are enabling faster access to insights that can support more efficient care and informed treatment decisions.”

“This approval underscores how NeuroPace’s data advantage is translating into practical tools for clinicians today,” said Joel Becker, Chief Executive Officer of NeuroPace. “AI-driven insights offer the unique potential to improve the efficiency of epilepsy care now while building a platform that can unlock new opportunities over time to further personalize therapy and improve outcomes.”

Advanced Debut

NeuroPace plans to officially debut ECoG Assistant at the American Society for Stereotactic and Functional Neurosurgery (ASSFN) Annual Meeting on May 30th, 2026, where clinicians will experience the new technology firsthand.

Next-Generation PDMS (Pending FDA Review): A Cloud-Based Foundation for Future AI Innovation

NeuroPace has also submitted its next-generation Patient Data Management System (PDMS) for FDA review, which is designed to modernize the underlying software infrastructure that supports the RNS System. If approved, this platform is expected to improve reliability and scalability for clinicians and patients and provide a more flexible foundation to support AI-enabled capabilities, including additional workflow tools like the recently approved ECoG Assistant and other future applications. The company currently expects Next-Generation PDMS approval in the second quarter of 2026.

About NeuroPace, Inc.

Based in Mountain View, Calif., NeuroPace is a medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differentiated RNS^® System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. This platform can drive a better standard of care for patients living with drug-resistant epilepsy and has the potential to offer a more personalized solution and improved outcomes to the large population of patients suffering from other brain disorders.

Forward Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. NeuroPace may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding: NeuroPace’s expectations and beliefs about the benefits and capabilities associated with its software, technology and other product development efforts, including but not limited to ECoG Assistant™, the potential impact of these developments on epilepsy care and the ability of these developments to drive adoption of the RNS^® System. These statements are neither promises nor guarantees but involve known and unknown risks, uncertainties, and other important factors that may cause NeuroPace’s actual results or events to be materially different from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks related to product development, including risks related to the further development of AI-powered software and the next generation, cloud-based PDMS, and risks related to regulatory compliance and expectations for regulatory submissions and approvals of future AI-powered software tools; and other important factors. These and other risks and uncertainties include those described more fully in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in NeuroPace’s public filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 3, 2026, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 12, 2026, as well as any other reports that it may file with the SEC in the future. Forward-looking statements contained in this announcement are based on information available to NeuroPace as of the date hereof. NeuroPace undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing NeuroPace’s views as of any date subsequent to the date of this press release and should not be relied upon as a prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of NeuroPace.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260529539764/en/

Investor Contact:
Scott Schaper
Head of Investor Relations
sschaper@neuropace.com
investors@neuropace.com

Source: NeuroPace, Inc.