New Version of Adjunctive MRI Neuroimaging Software Gets FDA Nod

The Food and Drug Administration (FDA) has granted 510(k) clearance to version 2.1 of the ClearPoint Neuro Navigation software, which can be utilized in conjunction with magnetic resonance imaging (MRI) for stereotactic guidance during neurosurgical procedures.

Reserved for use with 1.5 and 3.0 Tesla MRI scanners, the latest version of the ClearPoint Neuro Navigation software features trajectory planning tools, improved detail of imaging data sets and other technical improvements to enhance neurosurgical workflows, according to the company.

ClearPoint Neuro said the software, which facilitates the use and placement of instruments and devices in neurosurgical procedures, can be utilized for biopsy procedures as well as catheter and electrode insertion, including lead placement for deep brain stimulation.

“In addition to offering new image visualization capabilities and performance improvements, this version offers a rich set of functionalities which will strengthen an already comprehensive set of trajectory planning and guidance tools within the software,” noted Tim Orr, a vice president of software engineering at ClearPoint Neuro. “Over the years of developing an image-guided platform for neurosurgical procedures, we have paid very close attention to the differing workflows that clinicians have used within our system and have incorporated several important features in this version which we believe will better optimize their interoperative clinical workflows.”

ClearPoint Neuro noted the new version of the Neuro Navigation software, currently in limited market release, will initially be available for those who participate in the company’s Pathfinder program. This program cultivates the discovery of innovations in patient care, according to ClearPoint Neuro.