ClearPoint Neuro Gains 510(k) Clearance for Brain Model Software

ClearPoint Neuro has gained 510(k) clearance from the FDA for its ClearPoint Maestro brain model software for analysis of magnetic resonance imaging (MRI) images.

The software delivers accurate models of the brain for use by neurosurgeons, automating the process of labeling and quantifying the volume and shape of brain structures visible in the MRI images.

Now that the standalone patient analysis tool is clear, the company plans to include the software in its ClearPoint Navigation platform and add new functionality.

The brain model software is the result of a February 2021 collaboration deal between ClearPoint and Philips.