ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0
Shots:
- The US FDA has granted 510(k) clearance to ClearPoint Navigation Software 3.0 that will introduce intraoperative CT workflow, expanding its use from MRI. The company is planning to initiate limited market release in Q1’25 & full release in H2’25
- Navigation Software 3.0 is compatible with intraoperative CT & Conebeam CT imaging, enabling precision neurosurgery in facilities lacking intraoperative MRI
- Also, the latest version with the SmartFrame XG stereotactic frame, provides precise stereotactic guidance for neurosurgical procedures, incl. biopsies, catheter & electrode insertion, plus deep brain stimulation (asleep/awake) lead placement
Ref: ClearPoint Neuro | Image: ClearPoint Neuro
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.