Ceribell, Inc.

BrainSpace, a MedTech company focused on neuro injury, announced it received FDA 510(k) clearance for its offering Intellidrop, a brain fluid management system that allows for cerebrospinal fluid drainage at the bedside. Cerebrospinal fluid (CSF) is a transcellular liquid that surrounds and protects the brain and spinal cord. It acts as a shock absorber, allowing the brain to float. It also provides a stable environment for the central nervous system. Disruption of CSF can lead to changes in intracranial pressure and brain blood flow, which can lead to disability. "We've heard from hundreds of ICU nurses that automating external CSF clearance is going to be a huge relief for nurses and a better experience for patients with Traumatic Brain Injury (TBI), stroke, skull base tumor surgeries, neurodegenerative conditions like Normal Pressure Hydrocephalus and more," Caitlin Morse, cofounder and CEO of BrainSpace, said in a statement. "That hope can now become a reality in hospitals around the US with Intellidrop FDA cleared." Ceribell , a company focused on neurological conditions, has received FDA breakthrough device designation for its large-vessel occlusion (LVO) stroke-detection monitor for hospitalized patients. The LVO stroke detection monitor combines Ceribell's existing point-of-care EEG hardware with an AI algorithm to enable continuous neurological monitoring at the bedside. "Stroke is a devastating condition, but one where quick access to treatment can make a lifetime of a difference," Jane Chao, cofounder and CEO of Ceribell, said in a statement. "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." Naox Technologies, a neurotechnology company specializing in brain monitoring, has received FDA 510(k) clearance for Naox Link, an in-ear EEG device embedded in an ear plug that records brain electrical activity. Naox Link uses a small sensor in the ear to capture, record and transmit brain activity, replacing the traditional setup of at least 20 electrodes with conductive gels that allow for mostly short recordings. The company said Naox Link can be used in both home and healthcare settings. The device is meant for use in neurology and epilepsy care, sleep medicine and clinical research. "EEG readings have traditionally been constrained by short recording windows, uncomfortable headgear, and clinical settings that fail to reflect patients’ real lives," Hugo Dinh, cofounder and CEO of Naox Technologies, said in a statement. "With FDA clearance of Naox Link, clinicians can extend EEG into everyday environments, enabling longer, repeated more natural recordings and opening new possibilities for understanding brain activity beyond the clinic."

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.”

Ceribell said it has received FDA 510(k) clearance for its delirium monitoring solution, making it the first delirium screening and monitoring device cleared by the agency. The Sunnyvale, CA-based company said the clearance further establishes the Ceribell System as an AI-powered brain monitoring platform technology, extending the benefits to a larger population of critically ill patients and providing additional information to assist in diagnosing patients at risk for both seizures and delirium. Ceribell’s delirium monitoring solution continuously analyzes EEG segments and notifies clinicians when patterns associated with delirium are detected, supporting more timely, reliable evaluation and continuous monitoring of delirium. This will allow the Ceribell System to simultaneously support continuous seizure, electrographic status epilepticus (ESE), and delirium monitoring at the bedside. Analysts expressed enthusiasm for the clearance, which came earlier than expected. “We see this clearance as Ceribell executing on another of the growth pillars we outlined in our recent note — building out a multi-indication platform (neonate/pediatrics, delirium, stroke) on top of a still-only 3% penetrated [total addressable market] and a ramping TM/CAM commercial model,” wrote Brandon Vazquez, a medtech analyst at William Blair. Vazquez noted that delirium monitoring targets a large, overlapping ICU population where Ceribell already has a presence for seizure detection and where the clinical literature suggests a tight link between seizures and delirium. “In our view, this should support deeper utilization in existing accounts,” he wrote. “Combined with recent neonatal Clarity clearance, VA expansion, and ongoing protocolization work, we continue to see the setup into 2026 as favorable, with multiple shots on goal for upside to Street estimates as these indications commercialize.” BTIG medtech analysts recently named Ceribell as their 2026 small-cap top pick. “Since its IPO in late 2024 , the company has reported consistent beats and raises, with many near- and long-term catalysts ahead to fuel significant growth,” BTIG’s Marie Thibault wrote in a research note issued December 3. According to Ceribell, delirium affects about 31% of ICU patients and up to 80% of those who are mechanically ventilated. The condition is associated with poor clinical outcomes, including a 10% higher six-month mortality risk for every day delirium is experienced, as well as longer hospital stays and increased hospitalization costs, the company noted. Ceribell also said the risk of post-ICU dementia is 60% higher in discharged ICU patients who have had delirium, compared to those who have not had delirium in the ICU. Ceribell said the condition often goes unrecognized due to challenges in clinical assessment and the lack of objective, continuous monitoring tools. The company noted that its delirium monitoring solution addresses this gap by providing real-time, objective neurological insights at the bedside. “Delirium has been under recognized and under treated in critically ill patients for far too long, despite its strong association with poor outcomes,” said Jane Chao, PhD, co-founder and CEO of Ceribell. “With this FDA clearance, Ceribell is 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.” Chao said the company expects to finalize its go-to-market strategy “in the near future” and plans to leverage its existing commercial footprint and reputation in AI-based neuro monitoring to bring the technology to patients in need. “This is another big step towards our mission of making EEG a new vital sign for better brain care,” Chao said.