Ceribell Wins FDA Breakthrough Status for LVO Stroke Tool

Ceribell, Inc. ( (CBLL) ) has issued an announcement.

On January 5, 2026, Ceribell announced that the U.S. Food and Drug Administration granted Breakthrough Device Designation for its Large Vessel Occlusion (LVO) stroke detection and monitoring solution, which uses the company’s existing EEG hardware and an AI-based algorithm to identify LVO strokes in hospitalized patients. As a first-in-class point-of-care EEG application for LVO stroke, the designation underscores Ceribell’s strategy to extend its brain-monitoring platform to new, high-acuity indications following recent 510(k) clearances for neonatal seizure detection and delirium monitoring, and highlights the potential to improve outcomes in the sizable and often underserved in-hospital stroke population, where detection delays are associated with significantly higher mortality and long-term disability.

The most recent analyst rating on (CBLL) stock is a Hold with a $22.50 price target. To see the full list of analyst forecasts on Ceribell, Inc. stock, see the CBLL Stock Forecast page.

Spark’s Take on CBLL Stock

According to Spark, TipRanks’ AI Analyst, CBLL is a Neutral.

The score is held back primarily by ongoing large losses and meaningful cash burn despite strong revenue growth and very high gross margins. Technical trends are strongly positive, and raised guidance plus FDA clearances support the growth narrative, but negative earnings (negative P/E) and expense-driven loss widening keep overall risk elevated.

To see Spark’s full report on CBLL stock, click here.

More about Ceribell, Inc.

Ceribell, Inc. is a Sunnyvale, California–based medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. Its core product, the Ceribell System, is a novel point-of-care electroencephalography (EEG) platform that combines highly portable, rapidly deployable hardware with artificial intelligence–powered algorithms to enable rapid diagnosis and continuous monitoring of neurological conditions in acute-care settings such as intensive care units and emergency rooms. The system is already FDA-cleared in the U.S. for detecting seizures and delirium.

Average Trading Volume: 426,019

Technical Sentiment Signal: Strong Buy

Current Market Cap: $790.1M

Find detailed analytics on CBLL stock on TipRanks’ Stock Analysis page.