FDA Approves ClearPoint Neuro's Updated Software For Guidance System For Neurological Procedures

  • The FDA granted 510(k) clearance for ClearPoint Neuro Inc's CLPT 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 the planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. 
  • The ClearPoint System is integral to procedures that traditionally use stereotactic methodologies, such as biopsies, catheter and electrode insertion, and deep brain stimulation (DBS) lead placement. 
  • Related: ClearPoint Neuro Stock Dives After Q2 Earnings.
  • The system is only used with 1.5 and 3.0 Tesla MRI scanners.
  • The primary customer benefits of the 2.1 software include optimizing ease for clinicians' use, enhanced visualization of medical image datasets, new trajectory planning tools, new workflow tools for gene therapy trials, and numerous performance and technical improvements. 
  • The software is currently in limited market release. It will be deployed initially to ClearPoint customers who participate in the ClearPoint "Pathfinder" Program.
  • Price Action: CLPT shares are down 2.44% at $11.20 on Tuesday.
Posted In: NewsHealth CareFDAGeneralBriefs
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