ClearPoint Neuro Gains FDA Clearance for its ClearPoint Array System

The FDA has granted 510(k) clearance to ClearPoint Neuro’s ClearPoint Array System for use in stereotactic surgery — a minimally invasive form of surgery that uses a three-dimensional coordinate system to locate small targets inside the body.

The device can provide guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures while magnetic resonance imaging is going on.

ClearPoint Array is intended as an integral part of procedures, such as biopsies, catheter and electrode insertion, including deep brain stimulation lead placement. The system is intended for use with 1.5 and 3.0 Tesla magnetic resonance imaging scanners.