Case Study: Medical Device Company achieves FDA-approved neural implant navigation and US clinic certification with Intetics

Medical Device Company Received a New Application That Helps Surgeons Navigate Neural Implant Insertion

Medical Device Company, a developer of therapies for CNS diseases, needed an FDA-compliant application to help surgeons navigate neural implant insertion as it pursues treatments for acute ischemic stroke. They engaged Intetics to design and implement the complete software and system stack (C++/ML/AI/Qt, VTK, DICOM, CT/MPR and related technologies) to meet regulatory and clinical requirements.

Intetics delivered 100% of the application and supporting hardware/software complex within 12 months, producing an FDA-approved solution that enables certification and US clinic sales. As a result, the Medical Device Company can run the ImPACT-24b multi‑national, 24/7 study, focus on medical innovation instead of technical details, and begin commercial deployment.