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Home » ClearPoint Neuro to commercialize FDA-cleared neuro laser

ClearPoint Neuro to commercialize FDA-cleared neuro laser

September 23, 2022 By Chris Newmarker

Marketing image of the ClearPoint Prism neuro laser therapy system created by Clinical Laserthermia Systems and commercialized by ClearPoint Neuro
The ClearPoint Prism neuro laser therapy system [Image courtesy of ClearPoint Neuro]
ClearPoint Neuro (Nasdaq: CLPT) announced today that the FDA has cleared its Swedish partner Clinical Laserthermia Systems’ neuro laser therapy system.

The plan is for ClearPoint Neuro to commercialize the system as the ClearPoint Prism. The company has exclusive global rights to commercialize the CLS magnetic resonance (MR) guided laser interstitial thermal therapy (MRgLITT) system. The system is for neuro applications.

The ClearPoint Neuro navigation system has FDA clearance and a CE mark. The company has it installed in over 60 active sites in the United States, Canada, and Europe. In addition, the company has partnerships with more than 45 pharmaceutical and biotech companies. Applications it’s pursuing include drug delivery to the brain. Also, ClearPoint Neuro is active in the hot brain-computer interface space. It is working with Blackrock Neurotech to automate BCI implantation.

“Over the past decade, the ClearPoint Neuro Navigation System has offered an efficient one-room solution to assist neurosurgeons in the United States and Europe to accurately place laser fibers and help treat brain tumors, radiation necrosis, and epileptic foci in thousands of patients,” ClearPoint Neuro CEO Joe Burnett said in a news release.

Burnett said the company looks forward to commercializing the laser therapy treatment in the coming years. “This is another example of the innovation that ClearPoint is delivering to the neurosurgery and spine community through our team and our expert partners.”

More about ClearPoint Prism

Laser interstitial thermal therapy could prove to be a minimally invasive and powerful treatment for various neurological diseases, according to Dr. John Rolston, director of the Mapping & Engineering Neural Dynamics Laboratory at Brigham & Women’s Hospital and Harvard Medical School.

“The new laser system offered by ClearPoint has several exciting technical innovations that are expected to make this therapy simpler and more accessible to surgeons and their patients,” Rolston said.

The ClearPoint Prism neuro laser therapy system is currently in a limited market release. It’s at select academic medical centers in the United States.

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Imaging, Neurological, News Well, Regulatory/Compliance, Surgical Tagged With: ClearPoint Neuro, Clinical Laserthermia Systems

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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