ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced receipt of European Medical Device Regulation (EU MDR) clearance for the manual SmartTwist® MR Hand Drill and SmartTip® MR Drill Kit. Additionally, the Company received updated certification from its Notified Body allowing for shipment of products manufactured at its new Carlsbad, California facility to Europe.
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