Brain Science Tools B.V.

Brain Science Tools B.V. specializes in surgical planning and navigation-enhancement systems. Their primary focus is on tools that integrate imaging data with real-time intraoperative guidance, such as their Neural Navigator, which aids in improving precision during neurosurgical procedures.

Brain Science Tools B.V. is headquartered in the United States. The company’s location is relevant for understanding regulatory oversight and compliance frameworks that may apply to its devices.

Brain Science Tools B.V.’s devices fall under the FDA’s Class II classification. This classification indicates a moderate level of risk and regulatory scrutiny, requiring compliance with specific controls to ensure safety and effectiveness before market authorization.

Yes, Brain Science Tools B.V.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system helps ensure traceability, transparency, and compliance with post-market surveillance requirements for Class II devices.