ClearPoint Neuro (Nasdaq:CLPT) announced that the FDA cleared its ClearPoint 2.2 software with integrated Maestro Brain Modeling.
The Solana Beach, California-based company also reported the first-in-human cases following the FDA clearance.
ClearPoint Neuro President and CEO Joe Burnett said the system now offers fast, peri-procedural segmentation of the cortical structures of the brain. This helps to identify targets and safety zones for cell and gene therapy delivery, laser ablation, biopsy and deep brain stimulation.
According to the company, MRI-guided neuro interventions need rapid, accurate and reproducible segmentation of brain structures. Maestro demonstrates superior performance compared to both manual expert segmentation and FreeSurfer, according to quantitative analysis.
The company expects a full market release of ClearPoint 2.2 in the second half of 2024.
“Leadership and innovation in any medical field requires not only practical product development to deliver value for clinicians, but also robust validation and peer review to show how and why those products work,” Burnett said in a news release. “The Maestro Brain Model, and its integration into the recently FDA cleared ClearPoint 2.2 navigation software, is our latest example of just that.”
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The company provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and CE mark.