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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."
