ClearPoint Neuro receives US FDA 510(k) clearance for its Prism Bone Anchor Accessory
Overview
ClearPoint Neuro, Inc, a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, announced it has received 510(k) clearance for its Prism Bone Anchor Accessory. This clearance marks the company’s second new product introduction within the first four months of 2024.
Support for novel Prism Bone Anchor Accessory
- “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,” stated Chris Osswald, 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. 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.”
Use of Accessory
The Prism Bone Anchor Accessory is intended to be used with commercially available stereotactic systems for intracranial and neurosurgical procedures which require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain or nervous systems. It is designed to provide short-term fixation and positioning of compatible neurosurgical instruments or accessories under image-guidance.
ClearPoint Neuro
- ClearPoint Neuro uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery.
- The Company’s flagship product, the ClearPoint Neuro Navigation System, has US FDA clearance and is CE-marked.
- ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America.
- The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide.
- To date, thousands of procedures have been performed and supported by the company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide.
