Ceribell wins FDA Breakthrough Device Designation for ai-powered LVO stroke detection System. The Sunnyvale, CA-based firm's EEG-based solution uses artificial intelligence algorithms to identify large vessel occlusion strokes in hospital patients. The Ceribell System is a portable EEG platform. Image courtesy of Ceribell Ceribell has won Breakthrough Device Designation for its large vessel occlusion stroke detection and monitoring solution. This 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. "Stroke is a devastating condition, but one where quick access to treatment can make a lifetime of a difference," said Jane Chao, PhD, 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 Sunnyvale, CA-based company said the designation builds on recent FDA 510(k) clearances for its next-generation Clarity algorithm to detect electrographic seizures in neonates and its delirium screening and monitoring solution. In a research note, Brandon Vasquez, an analyst with William Blair, wrote, "We expect that FDA approval for stroke is likely still a few years out, but given the FDA approval for delirium was in line to slightly ahead of expectations, we believe it could be on the earlier side of that time frame." Vasquez went on to write, "Shares are roughly flat on the news, and we continue to believe our thesis on the compelling 2026 to 2027 setup is playing out. We wait for more updates on how much management expects catalysts like the pediatric/neonate rollout and delirium indication to impact 2026 revenue numbers next week. We expect the former to contribute more meaningfully, given the latter will likely go through a pilot phase before a large-scale rollout." All eyes are on Ceribell because the company went public in 2024, when IPOs were a rarity in medtech. The firm, founded in 2014, successfully raised $180.3 million in its IPO - significantly exceeding its initial goal of $101 million. In a November research note, BTIG analyst Marie Thibault wrote about the company's position in the point-of-care EEG market. Thibault wrote, "Ceribell is the clear market leader and continues to be the dominant player in POC EEG systems." Omar Ford is a seasoned journalist specializing in medical technology, healthcare innovation, and the medical device and diagnostics industry. As the editor-in-chief of Medical Device + Diagnostics Industry (MD+DI), he has earned a reputation as a leading authority in the field, offering in-depth insights into the latest trends, regulatory changes, and technological advancements shaping the future of healthcare. Omar has been a featured speaker at MD&M and MEDevice events. Omar has written for several publications prior to MD+DI. He is a former contributor at Bioworld Medtech, an online publication owned by Clarivate. He was a general assignment reporter for the Beaufort Gazette and an education and county reporter for the Griffin Daily News. He is the 2001 winner of the Judson Chapman Award from the South Carolina Press Association and the 2003 McClatchy President's Award recipient. Omar has a bachelor's degree in print journalism from the University of South Carolina. Throughout his tenure at MD+DI, Omar has covered a wide array of topics, including medical technology innovations, regulatory affairs, market dynamics, and the growing impact of artificial intelligence in healthcare. Omar is the host of the Let's Talk Medtech podcast.

SUNNYVALE, Calif., Sept. 22, 2025 (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 the appointment of Erica Rogers to its Board of Directors.

SUNNYVALE, Calif., May 20, 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 Jane Chao, Ph.D., CEO and Co-founder, will present at the upcoming William Blair 45th Annual Growth Stock Conference. The presentation will take place on Tuesday, June 3, 2025, at 7:20 a.m. Pacific Standard Time / 9:20 a.m. Central Standard Time.Event: William Blair 45th Annual Growth Stock ConferenceDate: Tuesday, June 3, 2025Time: 7:20 a.m. PST / 9:20 a.m