ClearPoint Neuro Announces FDA Approval for Software Version 2.1

ClearPoint Neuro Announces FDA Approval for Software Version 2.1

ClearPoint Neuro, Inc., a global therapy platform company that provides navigation and delivery to the brain, today announced that it has obtained 510(k) approval for version 2.1 of the ClearPoint Neuro Navigation software.

Version 2.1 of the ClearPoint System is intended to provide stereotaxic guidance for the placement and operation of instruments or devices when planning and performing neurological procedures in the MR environment and in conjunction with MR. The ClearPoint system intends to be an integral part of the procedures that traditionally use the stereotaxic methodology. These procedures involve inserting a biopsy, catheter, and electrodes, including the placement of deep brain stimulation (DBS) electrodes. The system is intended for use with Tesla MR 1.5 and 3.0 scanners only.

Key customer benefits of the 2.1 software include improved ease of use for clinicians, improved visualization of medical imaging datasets, provision of a new set of trajectory planning tools, the introduction of new tools workflow for clinical trial gene therapy clinicians, and numerous technical and performance improvements that will help streamline and streamline clinical workflow. The software is currently in a limited market release and will initially be distributed to ClearPoint customers participating in the ClearPoint “Pathfinder” program. Pathfinder is designed to support and facilitate the first-hand discovery of innovative developments that can facilitate optimal patient care by giving participating customers access to ClearPoint Neuro’s advanced technology.

Phil Hotte, Chief Software Architect at ClearPoint Neuro, said, “This latest release builds on the tremendous success of ClearPoint software, including many new features and improvements suggested by our users, as well as the launch of the next generation of products. ClearPoint “It’s a big achievement for us, but it’s just the beginning. Our journey will take full advantage of the capabilities of the newly released ClearPoint Maestro™ brain model, which will provide us with a new engine to drive innovation across all of our products.”

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