FDA Clears Automated Cerebrospinal Fluid Drainage and Intracranial Pressure Monitoring Device

The Food and Drug Administration (FDA) has granted 510(k) clearance for Intellidrop (BrainSpace, Seattle, WA), an automated brain fluid management system for use in cerebrospinal fluid (CSF) drainage and intracranial pressure (ICP) monitoring. The device integrates proprietary hardware and software to provide continuous brain pressure measurement and closed-loop, gravity-driven drainage of CSF to a personalized volume or pressure target.

Intellidrop is indicated for external drainage of CSF and/or monitoring of CSF drainage and ICP for both ventricular and lumbar applications. According to BrainSpace, the system is designed to automate aspects of external CSF management that are traditionally performed manually, combining pressure sensing with automated control of fluid drainage. The clearance applies to use across a range of neurologic and neurosurgical settings where external CSF drainage and ICP monitoring are clinically indicated.

Source: BrainSpace. FDA clears BrainSpace Intellidrop, an automated neuro device that addresses ICU nursing shortages and builds training data for physical AI. PR Newswire. Published January 2, 2025. Accessed January 5, 2025. https://prnmedia.prnewswire.com/news-releases/fda-clears-brainspace-intellidrop-an-automated-neuro-device-that-addresses-icu-nursing-shortages-and-builds-training-data-for-physical-ai-302651917.html