ClearPoint Neuro Announces FDA Clearance for Software Version 2.1

SOLANA BEACH, Calif., Sept. 19, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced that it has obtained 510(k) clearance for version 2.1 of the ClearPoint Neuro Navigation software.

Version 2.1 of the ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.

The main customer benefits of the 2.1 software include optimizing ease of use for clinicians, enhancing visualization of medical image datasets, providing a new set of trajectory planning tools, introducing new workflow tools for gene therapy clinical trials, and numerous performance and technical improvements which will help to streamline and optimize the clinical workflow. The software is currently in limited market release and will be deployed initially to ClearPoint customers who participate in the ClearPoint “Pathfinder” Program. Pathfinder is designed to support and cultivate first-hand discovery of innovative developments that may facilitate optimal patient care by providing participating customer sites with access to ClearPoint Neuro’s cutting-edge technology.

“The release of the ClearPoint 2.1 Software is a fantastic achievement for the company and provides our customer base with a significant set of software-related improvements which will enhance the usability of the product and optimize the clinical workflow,” commented Tim Orr, Vice President of Software Engineering at ClearPoint Neuro. “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. 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 with our system and have incorporated several important features in this version which we believe will better optimize their intraoperative clinical workflows. More importantly, this version has introduced numerous functional building blocks which we hope will lay the groundwork for significant future growth in the areas of preoperative planning, medical image visualization, and automatic image fusion. Our goal with this release is to continue to offer our customers a world-class image-guided planning and navigation software system that they feel confident using for preoperative planning and intraoperative guidance.”