BrainSpace has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Intellidrop, an automated brain fluid management system that integrates proprietary hardware and software for continuous brain pressure management and closed-loop, gravity-driven drainage of brain fluid to a personalized volume or pressure goal.

Intellidrop is the latest in an emerging lineup of brain fluid interface (BFI) products that measure, monitor, and act on the fluids of the brain. This includes cerebrospinal fluid, interstitial fluid, and cerebral blood. The device is indicated to provide external drainage of cerebrospinal fluid (CSF) and/or monitoring of CSF drainage and intracranial pressure (ICP) for ventricular or lumbar use.

BFI devices offer a continuous window into the brain’s health. Intellidrop generates novel, multimodal, contextualized data that is crucial in training physical AI models. The company said BFI technology has the potential to benefit patients across the spectrum of neurological 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’s co-founder and CEO. “That hope can now become a reality in hospitals around the US with Intellidrop FDA cleared.”

According to a Lancet study, one in three people on the planet will experience neuro injury, illness, or degeneration in their lifetime. The sooner a patient can access appropriate care, the lower the risk that brain injury results in severe, lifelong disability. BrainSpace believes its technology will make care more accessible and allow clinicians to introduce more personalized approaches.

BrainSpace was founded in 2021 and is a past winner of the Seattle Angel Conference, Flywheel Investment Conference and grand finalist in MedTech Innovator 2024.