Ceribell Inc. has received FDA Breakthrough Device Designation for its Large Vessel Occlusion $(LVO)$ stroke detection and monitoring solution. The device utilizes Ceribell's existing point-of-care EEG technology combined with an AI-based algorithm to aid in the early detection and monitoring of LVO strokes in hospital settings. This designation highlights the potential of the Ceribell System to improve timely and accurate LVO stroke detection, addressing a critical need for faster intervention and better outcomes for stroke patients. The recognition builds on Ceribell's recent regulatory milestones, including FDA 510(k) clearances for its Clarity® algorithm and delirium monitoring solution. No other beneficiary organizations were mentioned.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ceribell Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9619410-en) on January 05, 2026, and is solely responsible for the information contained therein.