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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

Related News:- Medidata (Dassault Systèmes brand) and Tigermed Expand their Strategic Collaboration to Expedite Clinical Trials Globally

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