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

ClearPoint Neuro Inc's 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.