ClearPoint Neuro Secures FDA Nod For ClearPoint Prism Neuro Laser Therapy System

ClearPoint Neuro Inc’s (NASDAQ:CLPT) Swedish partner, Clinical Laserthermia Systems (CLS), has received FDA 510(k) clearance for its laser, which the company…
  • ClearPoint Neuro Inc’s (NASDAQ:CLPT) Swedish partner, Clinical Laserthermia Systems (CLS), has received FDA 510(k) clearance for its laser, which the company plans to commercialize as the ClearPoint Prism Neuro Laser Therapy System.
  • The ClearPoint Prism Neuro Laser Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under 3.0T magnetic resonance imaging (MRI) guidance. 
  • Related: FDA Approves ClearPoint Neuro’s Updated Software For Guidance System For Neurological Procedures.
  • ClearPoint Neuro has exclusive global rights to commercialize the CLS magnetic resonance (MR) guided laser interstitial thermal therapy (MRgLITT) system for neuro applications. 
  • The system comprises a clinical solution combining the ClearPoint navigation platform, the laser technology from CLS, and a thermal ablation monitoring software, Thermoguide from France-based medical device company Image Guided Therapy SA (IGT).
  • The ClearPoint Prism Neuro Laser Therapy System is currently in limited market release at select academic medical centers across the U.S.
  • Price Action: CLPT shares are up 8.21% at $10.94 during the premarket session on the last check Friday.
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