Key Takeaways Ceribell received FDA Breakthrough Device Designation for its AI-based LVO stroke detection solution.CBLL is extending its point-of-care EEG platform beyond seizures and delirium into time-sensitive stroke care.The designation supports faster FDA interactions and earlier commercialization, boosting CBLL's visibility.CeriBell Inc. (CBLL) recently announced that the FDA has granted Breakthrough Device Designation for its Large Vessel Occlusion (LVO) stroke detection and monitoring solution desig ...

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 monitoringSUNNYVALE, 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 proprieta ...