Sam Brusco, Associate Editor04.29.24
ClearPoint Neuro has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Prism bone anchor accessory.
The Prism bone anchor accessory is used with commercial stereotactic systems for intracranial and neurosurgical procedures that need accurate positioning of compatible small surgical instruments or accessories in the cranium, brain, or nervous system.
It offers short-term positioning and fixation for those instruments or accessories under image guidance.
This is the company’s second product introduction in the first four months of 2024. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America.
“Similar to the recent launch of our SmartFrame OR platform, the introduction of the Prism Bone Anchor Accessory for use with the ClearPoint Prism Neuro Laser Therapy System supports our continued expansion beyond the MRI into the operating room. This is where most laser applicators are placed today,” said Chris Osswald, Ph.D., Director, Global Segment Leader for Laser Therapy at ClearPoint Neuro.
“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,” Dr. Osswald continued. “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.”
The Prism bone anchor accessory is used with commercial stereotactic systems for intracranial and neurosurgical procedures that need accurate positioning of compatible small surgical instruments or accessories in the cranium, brain, or nervous system.
It offers short-term positioning and fixation for those instruments or accessories under image guidance.
This is the company’s second product introduction in the first four months of 2024. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America.
“Similar to the recent launch of our SmartFrame OR platform, the introduction of the Prism Bone Anchor Accessory for use with the ClearPoint Prism Neuro Laser Therapy System supports our continued expansion beyond the MRI into the operating room. This is where most laser applicators are placed today,” said Chris Osswald, Ph.D., Director, Global Segment Leader for Laser Therapy at ClearPoint Neuro.
“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,” Dr. Osswald continued. “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.”