- ClearPoint Neuro ( NASDAQ: CLPT ) said its Swedish partner Clinical Laserthermia Systems (CLS) received the U.S. Food and Drug Administration's (FDA)510(k) clearance for its laser system to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under 3.0T magnetic resonance imaging (MRI) guidance.
- The company plans to commercialize the laser as ClearPoint Prism Neuro Laser Therapy System, which is currently in limited market release at select academic medical centers in the U.S., the company said in a Sept. 23 press release.
- The company noted that system consists of ClearPoint navigation platform, laser technology from CLS, and a thermal ablation monitoring software called Thermoguide from French medical device maker Image Guided Therapy.
- ClearPoint added that it has exclusive global rights to commercialize the CLS magnetic resonance (MR) guided laser interstitial thermal therapy (MRgLITT) system for neuro applications.
For further details see:
ClearPoint partner gets FDA clearance for laser therapy system