FDA Clears BrainSpace Intellidrop, an automated neuro device that addresses ICU nursing shortages and builds training data for Physical AI

SEATTLE, Jan. 2, 2026 /PRNewswire/ -- BrainSpace, a medical technology company building automated solutions for neuro injury, illness and degeneration, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Intellidrop, an automated brain fluid management system integrating proprietary hardware and software to achieve continuous brain pressure measurement and closed-loop, gravity-driven, precision drainage of brain fluid to a personalized volume or pressure goal.

"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," shares Caitlin Morse, BrainSpace CEO & Co-founder. "That hope can now become a reality in hospitals around the US with Intellidrop FDA cleared." The Intellidrop 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.

According to a recent Lancet study, 1 in 3 people on the planet will face neuro injury, illness or degeneration in their lifetime. For these 2.5 billion people globally, better solutions can't come soon enough. Time is Brain. The sooner a person can access appropriate care, the lower the risk that brain injury results in severe life-long disability. Automating brain pressure management simplifies the workflow for hospitals and staff. BrainSpace believes this will make care more accessible and allow for clinicians to introduce more personalized approaches.

The Intellidrop is the latest in an emerging group of Brain Fluid Interface (BFI) products that measure, monitor and act upon the fluids of the brain including cerebrospinal fluid, interstitial fluid, and cerebral blood. BFI devices provide a continuous window into the health of the brain. Intellidrop generates novel, multimodal, contextualized data that is key to training Physical AI models. BFI technology holds the potential to drive patient benefit across the spectrum of neuro disease at every age.

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.

For more information, see www.brainspacemed.com.

SOURCE BrainSpace