ClearPoint Neuro Gains 510(k) Clearance for Its Version 2.1 Software

Solana Beach, Calif.-based ClearPoint Neuro has received 510(k) clearance from the FDA for version 2.1 of its ClearPoint Neuro Navigation software for use in image-guided surgical procedures.

The software can be used to assist in navigation during biopsies, and catheter and electrode insertion, including the placement of deep brain stimulation leads.

Version 2.1 is intended to provide guidance for the placement and operation of instruments or devices during planning and procedures that make use of 1.5 and 3.0 Tesla magnetic resonance imaging (MRI) scanners.

The updated software features new planning tools, workflow tools for gene therapy clinical trials and improved performance, the company said.