Shares of ClearPoint Neuro Inc (NASDAQ:CLPT) rose 5.2% in premarket trading on Friday after the company said it had obtained EU MDR Certification for its ClearPoint Navigation Software Version 3.0.2.
The approval enables the company to deploy a single navigation platform across global markets, a move expected to simplify user training and hospital IT integration. The software received U.S. FDA clearance nearly a year ago and has since been adopted by the majority of ClearPoint Neuro’s customers in the United States.
“By achieving CE Mark for the ClearPoint Navigation 3.0.2 software, we are able to unify our global navigation platform which we believe will enable consistent training and hospital IT support,” said Mazin Sabra, Chief Operating Officer at ClearPoint Neuro. “We expect that this will also help us to not only satisfy our biopharma partners who want a global solution, but also reduce our operating costs and drive economies of scale.”
Version 3.0.2 introduces an intraoperative CT workflow, building on more than ten years of experience in stereotactic neurosurgical procedures. Earlier versions of the platform were designed solely for MRI-guided workflows, while the latest release expands functionality to operating room settings by supporting both intraoperative CT and cone-beam CT imaging.
The broader imaging compatibility is intended to extend access to precision-guided neurosurgery, particularly for hospitals that do not have intraoperative MRI systems, potentially expanding ClearPoint Neuro’s addressable market.