Regulatory Science Tool for Transcranial Ultrasound Modeling

The FDA is seeking a contractor to develop a computational modeling package for simulating transcranial ultrasound sonication protocols as a regulatory science tool. The tool will be used to mitigate uncertainties and support consistent evaluation of medical device safety and performance. The contractor will be responsible for developing a computational modeling package, validating it using ex vivo skulls and statistical analysis, and creating patient reference models. The contract will be for a period of 12 months, and the contractor will be required to deliver all required deliverables within this timeframe. • The contractor will develop a computational modeling package for simulating transcranial ultrasound sonication protocols. • The package will be validated using ex vivo skulls and statistical analysis. • The contractor will create patient reference models, including baseline, best-case, and worst-case models. • The contractor will provide comprehensive documentation, including a user guide, technical reference manual, and validation report. • The contractor will support FDA dissemination activities, including stakeholder meetings and workshops.