ClearPoint Neuro (Nasdaq:CLPT) announced today that the FDA granted 510(k) clearance for its Prism bone anchor accessory.
It marks the second new product introduction in 2024 for the company, with its stereotactic guidance system garnering clearance in January.
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The Prism system features the only non-cooled laser applicator on the market, the company said. Its next-generation laser applicator technology eliminates the need for external cooling. This simplifies setup, reduces power and ablation time and lessens imaging artifact for more efficient workflows.
ClearPoint Neuro designed its Prism bone anchor accessory for use with commercially available stereotactic systems. These systems work for intracranial and neurosurgical procedures. Such procedures require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain or nervous systems.
The anchor provides short-term fixation and positioning of those instruments or accessories under image guidance.
Chris Osswald, director, global segment leader for laser therapy, said the clearance supports continued expansion into the OR.
“We are pleased to round out our laser portfolio and look forward to working with hospitals in the United States interested in the Prism System that may have challenges with MRI access,” Osswald said. “We plan to begin our limited market release on schedule here in the second quarter, with a full market release in the second half of 2024.”
