ClearPoint Neuro CLPT announced the U.S. Food and Drug Administration (FDA) 510(k) clearance to its Maestro Brain Model, intended for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MRI images.
The Maestro software is developed to automate the process of identifying, labelling, and quantifying the volume and shape of brain structures visible in MRI images.
Joe Burnett, President and CEO, commented : "This is a tremendous milestone for ClearPoint and our collaboration with Philips as we are thrilled to introduce this new commercial tool into our portfolio. This is a crucial first step in our path to make the Maestro Brain Model the ‘engine' in our navigation system supporting multiple new applications in the future. Now that the standalone patient analysis tool is cleared, our development team will work to embed this software directly into the ClearPoint Navigation platform and add new functionality based on the priorities of the business.”
Lyubomir Zagorchev, Vice President of Clinical Science and Applications, said, "Having spent more than 10 years developing the Maestro software inside of Philips and now here at ClearPoint, I know firsthand the capability and potential of this software inside the ClearPoint platform.”
The company intends to execute the limited market release of Maestro Brain Model through the end of 2022.
Price Action : ClearPoint shares are trading around 7 percent higher at $15.50 on Tuesday during after-hours session.
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