FDA grants 510(k) clearance to stereotactic guidance system for neurosurgery

Key Takeaways:

• The SmartFrame OR system provides guidance of instruments or devices during surgery.
• The company plans a limited market release for the first half of 2024 and a full release later in the year.

The FDA has granted 510(k) clearance to a gene therapy-enabling company for a system that aims for greater accuracy in the placement and operation of instruments or devices in procedures for neurological conditions.

According to a press release from ClearPoint Neuro, its SmartFrame OR Stereotactic System is composed of the SmartFrame OR and the ClearPointer Optical Navigation Wand. In tandem, they provide health care professionals the ability to successfully navigate detailed surgical procedures in conjunction with compatible optical stereotaxic navigation systems that require preoperative MR and/or CT imaging, including biopsies, catheter placement and electrode introduction.

“This product is the first in ClearPoint’s history that does not require the use of MRI during the procedure, allowing us to access more hospitals and to support an order of magnitude more patients than our legacy portfolio,” ClearPoint President and CEO Joe Burnett said in the release. “More than 95% of all stereotactic neuro-navigation procedures take place in the OR, supporting [deep brain stimulation], laser ablation, biopsy, [stereoelectroencephalography] and more.”

ClearPoint said it plans to commence limited market release in the first half of 2024, with a full market release in the second half of 2024.