ClearPoint Neuro, a global leader in facilitating device, cell, and gene therapy, has recently secured FDA 510(k) clearance for its innovative SmartFrame OR™ Stereotactic System. This achievement marks a significant step for the company, renowned for its precise navigation solutions in neurosurgery.

Comprising the SmartFrame OR and the ClearPointer™ Optical Navigation Wand, the system delivers stereotactic guidance for instrument placement in neurological procedures, leveraging preoperative MR and/or CT imaging. Notably, the SmartFrame OR distinguishes itself as the first product in ClearPoint's history that eliminates the need for MRI during procedures, thereby expanding its reach to a broader spectrum of hospitals and supporting a larger patient base.

Crucially, the SmartFrame OR seamlessly integrates with existing neurosurgical operating room hardware and software, providing surgeons with flexible workflows. Its features, including iCT forward projection, enable precise image-based corrections, ensuring submillimetric accuracy in surgical interventions. This advancement underscores ClearPoint Neuro's commitment to advancing accessibility and accuracy in neurosurgical procedures.

Source: globenewswire.com

 

 

 

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