BrainSpace, a medtech focused on neurological injuries and illnesses, received 501(k) clearance from the FDA for its brain fluid management system designed to aid medical staff in providing improved patient care.
Dubbed Intellidrop, the system is capable of continuous brain pressure monitoring and precision brain fluid drainage, allowing clinicians to set and measure a patient’s target pressure or volume, the company said in a Jan. 2 press release.
The FDA clearance is indicated for external drainage of cerebrospinal fluid (CSF) and/or monitoring of CSF drainage and intracranial pressure (ICP) for ventricular or lumbar use.
BrainSpace’s system can generate key data to train physical artificial intelligence models. The technology, the company said, has the potential to boost patient benefits “across the spectrum of neuro disease at every age.”
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“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, stroke, skull base tumor surgeries, neurodegenerative conditions like normal pressure hydrocephalus and more,” Caitlin Morse, chief executive and co-founder of BrainSpace, said in a statement. “That hope can now become a reality in hospitals around the U.S. with Intellidrop FDA cleared.”
Back in 2022, fellow neurology-focused device maker Natus Medical, which debuted on the Nasdaq in 2001, agreed to be taken private in a $1.2 billion deal by private equity firm ArchiMed Group. The following year, Wisconsin-based Natus closed a deal to acquire Italy-based Micromed for an undisclosed amount, expanding its portfolio of neurodiagnostic and neuromonitoring products.
