Ceribell, Inc. announced that the U.S. Food and Drug Administration has granted 510(k) clearance for its proprietary delirium monitoring solution, the first and only FDA‑cleared device for continuous delirium screening in critically ill patients.
The new algorithm analyzes short EEG segments in real time and alerts clinicians when patterns associated with delirium are detected. By providing objective, continuous monitoring, the system addresses a critical unmet need in intensive care units, where delirium affects roughly 31 % of ICU patients and up to 80 % of those on mechanical ventilation. Early detection can reduce morbidity, shorten hospital stays, and lower costs associated with missed or delayed diagnoses.
This clearance expands the Ceribell System beyond its established seizure‑detection capability, positioning the company to capture a broader share of the acute‑care monitoring market. As the first FDA‑cleared device in this space, Ceribell gains a first‑mover advantage and reinforces its strategy of making EEG a new vital sign for patient care. The company’s breakthrough device designation in 2022 and its 2017 seizure‑monitoring clearance demonstrate a track record of regulatory success that supports this expansion.
Financially, Ceribell reported Q3 2025 revenue of $22.6 million, a 31 % year‑over‑year increase, while posting a net loss of $13.5 million. The company has submitted a New Technology Add‑on Payment application to Medicare and Medicaid, a pending step that will determine reimbursement and adoption rates for the new indication. The clearance is expected to accelerate commercial deployment and drive future revenue growth as the product moves from pilot to full market availability.
CEO Jane Chao said, “Delirium has been under‑recognized and under‑treated in critically ill patients for far too long, despite its strong association with poor outcomes. With this FDA clearance, we are 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.” The announcement was welcomed by investors, reflecting confidence in the company’s expansion into a high‑impact clinical area.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.