Clearpoint Neuro Receives Clearance It’s Prism Bone Anchor Accessory

Clearpoint Neuro Receives Clearance It’s Prism Bone Anchor Accessory

By, Admin 3 May 2024

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!