ClearPoint Neuro, Inc. (NASDAQ: CLPT) announced it received FDA 510(k) clearance for the Velocity Alpha MR High Speed Surgical Drill System and completed the first clinical procedure using the device. The system was used in a four-trajectory clinical trial procedure.

The pneumatic drill system is manufactured by German company adeor medical AG and designed to integrate with ClearPoint Neuro's SmartFrame navigation platform. The drill operates at up to 80,000 rpm and features specialized drill bits and cutters for neurosurgical applications.

The FDA cleared the system for trephination, incision, cutting, removal, shaping, and sawing of soft and hard tissue, bone and biomaterials in or near a magnetic field of 3.0 Tesla or less for neurosurgery use.

"The design of the drill bits provides tactile feedback during bone access, and facilitates consistent, predictable opening of the skull even during minimally invasive procedures where the bone is not fully visualized," said Dr. Paul Larson, ClearPoint Neuro's Chief Medical Officer and Professor of Neurosurgery at University of Arizona/Banner University Medical Center-Tucson.

The company stated the drill is designed to support multi-trajectory procedures, including cell and gene therapy cases, and integrate into workflows for complex neurosurgical applications. ClearPoint Neuro expects the drill to be compatible with its robotic navigation platform currently in development.

The system includes a universal cutter system with one-click coupling and integrated telescoping functionality designed for operating room personnel use.