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ClearPoint Neuro gets US FDA 510(k) clearance for its Prism Bone Anchor Accessory

ClearPoint Neuro, Inc., a global leader in device and therapy enablement for brain and spine, has received 510(k) clearance for its Prism Bone Anchor Accessory, marking the company's second new product launch in early 2024.

The Prism Bone Anchor Accessory is used with stereotactic systems in intracranial and neurosurgical procedures requiring precise instrument positioning in the cranium, brain, or nervous system. It provides temporary fixation and positioning under image guidance.

ClearPoint Neuro offers established pre-clinical development services and clinical products for drug and device delivery. Its flagship product, the ClearPoint Neuro Navigation System, has US FDA clearance and CE marking. The company collaborates with healthcare and research centers globally and partners with pharmaceutical and biotech firms, academic institutions, and contract research organizations. ClearPoint Neuro's clinical specialist team has supported thousands of procedures, providing extensive support to customers and partners worldwide.