BrainSpace, a medical technology company developing automated solutions for neurological injury, disease and degeneration, has received US Food and Drug Administration (FDA) 510(k) clearance for Intellidrop, its automated brain fluid management system.

Intellidrop combines proprietary hardware and software to enable continuous measurement of intracranial pressure and closed-loop, gravity-driven precision drainage of cerebrospinal fluid (CSF) to a personalised volume or pressure target. The system is indicated for external drainage and monitoring of CSF and intracranial pressure for both ventricular and lumbar use.

According to BrainSpace, the technology addresses a long-standing burden in intensive care units, where manual CSF drainage requires frequent nurse intervention and constant vigilance. By automating external CSF clearance, Intellidrop is designed to improve workflow efficiency while delivering more consistent and individualised patient care.

“We’ve heard from hundreds of ICU nurses that automating external CSF clearance would be a major relief and a better experience for patients,” said Caitlin Morse, chief executive officer and co-founder of BrainSpace. “With FDA clearance, that vision can now become a reality in hospitals across the US.”

The device is intended for use in patients with traumatic brain injury, stroke, skull-base tumour surgeries, and neurodegenerative conditions such as normal pressure hydrocephalus. BrainSpace noted that faster, more precise management of brain pressure can significantly reduce the risk of long-term neurological disability.

Citing recent global research, the company highlighted that nearly one in three people worldwide will experience neurological injury, illness or degeneration during their lifetime, underscoring the urgent need for scalable and personalised brain-care technologies.

Intellidrop is part of a growing class of brain fluid interface (BFI) devices that measure, monitor and act on key brain fluids, including cerebrospinal fluid, interstitial fluid and cerebral blood. These systems generate continuous, contextualised data that offer clinicians deeper insights into brain health and may support the development of advanced physical artificial intelligence models for neurological care.

BrainSpace believes that BFI technologies like Intellidrop have the potential to transform neurocritical care by improving outcomes, reducing staff burden and enabling more data-driven, personalised treatment approaches across the spectrum of neurological disease.