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Home » BrainSpace wins FDA clearance for automated brain fluid management device

BrainSpace wins FDA clearance for automated brain fluid management device

January 5, 2026 By Sean Whooley

BrainSpace IntelliDrop brain fluid management system
The IntelliDrop system. [Image from BrainSpace]
BrainSpace announced that the FDA granted 510(k) clearance for its Intellidrop automated brain fluid management system.

Seattle-based BrainSpace designed Intellidrop to integrate proprietary hardware and software to achieve continuous brain pressure measurement. It also aims to offer closed-loop, gravity-driven, precision drainage of brain fluid to a personalized volume or pressure goal.

The company said earlier access to appropriate neuro care can lower the risk that a brain injury results in severe, lifelong disability. Automating brain pressure management can simplify the workflow for hospitals and their staffs, the company says. This could make care more accessible and enable more personalized approaches for clinicians.

Intellidrop provides external drainage of cerebrospinal fluid (CSF) and/or monitoring of CSF drainage and intracranial pressure (ICP) for ventricular or lumbar use. BrainSpace labeled it a “brain fluid interface (BFI)” that can measure, monitor and act upon the fluids of the brain. It provides a continuous window into the brain’s health.

BrainSpace says the technology can generate novel, multimodal, contextualized data that proves key in training physical AI models. It believes its technology can drive patient benefit across the spectrum of neuro disease at every age.

“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,” said Caitlin Morse, BrainSpace CEO & co-founder. “That hope can now become a reality in hospitals around the U.S. with IntellidropFDA cleared.”

Founded in 2021, BrainSpace was a grand finalist in MedTech Innovator’s 2024 early-stage accelerator program. Read more about how Morse led the company through its startup phase here.

Filed Under: Artificial Intelligence (AI), Health Technology, Neurological, Software / IT Tagged With: BrainSpace, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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