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ClearPoint Neuro Announces FDA Clearance for ClearPoint Prism – Press Release

SOLANA BEACH, Calif., September 22, 2022 (GLOBE NEWSWIRE) — ClearPoint Neuro, Inc. CLPT (the “Company”), a global therapy platforms company that provides navigation and delivery to the brain, today announced that its Swedish partner Clinical Laserthermia Systems (CLS) has received 510(k) clearance for its laser, which the company plans to commercialize as the ClearPoint Prism™ neurolaser therapy system.

The ClearPoint Prism Neuro Laser Therapy System is indicated for soft tissue necrotization or coagulation by interstitial irradiation or thermal therapy under 3.0T magnetic resonance imaging (MRI). Full application notes can be found here: https://www.clearpointneuro.com/terms-of-service/label-indications/

ClearPoint Neuro has exclusive worldwide rights to commercialize the CLS Magnetic Resonance (MR)-guided Interstitial Laser Thermal Therapy (MRgLITT) system for neuro applications. The system includes a clinical solution that combines the ClearPoint navigation platform, laser technology from CLS and thermal ablation monitoring software called Thermoguide from French medical device company Image Guided Therapy SA (IGT).

“It’s wonderful to see new innovations in the field of interstitial laser thermal therapy. Laser ablation is an important and growing part of our surgical arsenal, offering minimally invasive and powerful treatments for a variety of neurological disorders,” said John Rolston, MD, PhD , Director of the Mapping & Engineering Neural Dynamics (MEND) Laboratory at Brigham & Women’s Hospital and Harvard Medical School. “The new laser system offered by ClearPoint has several exciting technical innovations designed to make this therapy easier and more accessible for surgeons and their patients.”

“Over the past decade, the ClearPoint Neuro-Navigation System has provided an efficient, one-room solution to assist neurosurgeons throughout the United States and Europe in the precise placement of laser fibers and in the treatment of brain tumors,…

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