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ClearPoint Neuro receives CE marking for surgical drill system

May 13, 2026 4:00 PM

ClearPoint Neuro Inc. (NASDAQ: CLPT) announced that its Velocity Alpha MR High Speed Surgical Drill System has received CE Marking for use in Europe, adding to its existing FDA 510(k) clearance in the United States.

The pneumatic drill system is manufactured by German company Adeor Medical AG and designed to integrate with ClearPoint Neuro's SmartFrame navigation platform. The device operates at up to 80,000 rpm and is cleared for trephination, incision, cutting, removal, shaping, and sawing of soft and hard tissue, bone, and biomaterials in magnetic fields of 3.0 Tesla or less for neurosurgery.

The system features specialized drill bits and cutters designed for multi-trajectory procedures, including cell and gene therapy cases. It includes a universal cutter system with one-click coupling and integrated telescoping functionality.

"Approval of this drill in Europe underscores the Company's strategy to expand its integrated product portfolio with complementary technologies designed to enhance procedural workflows," said Jeremy Stigall, Chief Business Officer & General Manager of Biologics & Drug Delivery at ClearPoint Neuro.

ClearPoint Neuro develops navigation systems for brain and spine procedures and provides preclinical development services for drug and device delivery. The company operates in North America, Europe, Asia, and South America, according to the press release.

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