ClearPoint Neuro, Inc. announced that it has received FDA clearance for version 1.1 of its next generation SmartFrame Array Neuro Navigation System and Software. The ‘Array' System, which was designed to streamline laser catheter insertion, brain biopsy, and drug delivery clinical trial procedures, has been in limited market release (LMR) since May 2021. During the limited release, SmartFrame Array was used in over 50 pre-clinical, clinical trial, and clinical procedures at 10 hospitals and clinical research organizations across North America.

Version 1.1 adds a pre-planning module that will further enhance workflows and reduce procedure time in both the MRI Suite and in the Operating Room (OR). The SmartFrame Array will be on display from April 29 – May 1 in the ClearPoint Neuro booth at the 2022 American Association of Neurological Surgeons Annual Scientific Meeting in Philadelphia, PA.