ClearPoint Neuro announces FDA clearance for ‘Navigation Software Version 3.0’

ClearPoint Neuro (CLPT) announced it has received 510 clearance for its ClearPoint Navigation Software Version 3.0. “As we prepare for the wave of new patients that will be treated with cell and gene therapies in the years ahead, it is crucial that ClearPoint helps healthcare providers be ready by providing simplified workflows, offering solutions to increase surgical capacity and expanding access to our hardware and software,” commented Joe Burnett, President and CEO at ClearPoint Neuro. “The newest ClearPoint 3.0 platform is designed to do exactly that by offering one of the fastest and most accurate navigation systems available while enabling the flexibility to be used in both the MRI suite and the operating room. Today, more than nighty-five percent of all stereotactic procedures in the United States take place in the operating room using Computed Tomography, CT, as the imaging modality. Using CT, the ClearPoint Software now supports the entire operating room procedure, eliminating the need for additional third-party navigation systems. Hospitals can use ClearPoint in either or both settings, benefiting from a consistent workflow that streamlines procedures and builds proficiency. We believe that this single, flexible solution will benefit our 50+ global biopharma partners with the potential to standardize cell and gene therapy delivery around the world, starting here in the United States.”