ClearPoint Neuro, a global device, cell, and gene therapy–enabling company specialising in precise navigation for brain and spine procedures, has announced that its ClearPoint Prism Neuro Laser Therapy System has received 510(k) clearance from the US Food and Drug Administration (FDA) for use under 1.5T MRI guidance, in addition to its previously cleared 3T MRI compatibility.

ClearPoint Prism is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under 1.5T and 3.0T MRI guidance in neurosurgery for a wavelength of 1064nm.

The company said that this expanded labeling could significantly increase the system’s market opportunity within the US, where 1.5T MRI systems account for approximately 60 percent of clinical use.

With 1.5T systems estimated to represent over 70 percent of the global installed MRI base, this clearance positions ClearPoint Prism for significant growth internationally as well.

"The expanded labeling for ClearPoint Prism is perfect timing for the company as it delivers added fuel to our 2025 growth initiatives, which we call Fast Forward," commented Joe Burnett, President & CEO at ClearPoint Neuro.

He continued, "This product will contribute meaningfully to these goals, both today and tomorrow. In the immediate term, we are excited to bring the benefits of ClearPoint Prism to hospitals that did not have the previously cleared MRI scanner available. As a reminder, our Functional Neurosurgery disposable products, including ClearPoint Prism laser applicators, grew 70 percent in the first quarter and 33 percent in the second quarter of this year. That growth was accomplished with one hand tied behind our back as we had access to less than 50 percent of the neuro LITT market. That hand is no longer tied. The longer-term benefits are more subtle but equally important.”

Chris Osswald, Director and Global Segment Leader for Laser Therapy, added that they plan to enter full market release on 1.5T immediately.