BrainSpace has received 510(k) clearance from the US Food and Drug Administration for Intellidrop, an automated brain fluid management system designed to improve the monitoring and drainage of cerebrospinal fluid in patients with neurological conditions. The clearance allows the system to be used clinically across hospitals in the United States.
Intellidrop combines proprietary hardware and software to enable continuous measurement of brain pressure and automated, closed-loop, gravity-driven drainage of cerebrospinal fluid to a personalised volume or pressure target. The system is indicated for external drainage of cerebrospinal fluid and for monitoring cerebrospinal fluid drainage and intracranial pressure in both ventricular and lumbar applications.
The technology is aimed at reducing the manual workload associated with cerebrospinal fluid management in intensive care settings while improving consistency and precision in care delivery. It is designed for use in patients with traumatic brain injury, stroke, skull base tumour surgeries, and neurodegenerative conditions such as normal pressure hydrocephalus.
According to findings published in The Lancet, nearly one in three people globally are expected to experience a neurological injury, illness or degenerative condition during their lifetime, highlighting the growing burden of brain-related disorders worldwide. Early and accurate management of brain pressure is considered critical in reducing the risk of long-term disability associated with neurological injury.
Intellidrop is part of an emerging category of brain fluid interface (BFI) technologies that measure, monitor and actively manage key brain fluids, including cerebrospinal fluid, interstitial fluid and cerebral blood. These systems provide continuous insight into brain health and generate multimodal, contextualised data that can support more personalised treatment approaches.
BrainSpace positions the automation of brain pressure management as a way to simplify clinical workflows, expand access to specialised neurological care and enable more individualised treatment strategies. The data generated by Intellidrop is also expected to contribute to the development of advanced physical artificial intelligence models, with potential applications across a broad range of neurological diseases and age groups.
