This Combined Synopsis/Solicitation opportunity from Department Of Health And Human Services was posted on August 26, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Regulatory Science Tool for Transcranial Ultrasound Modeling
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
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The FDA's Center for Devices and Radiological Health is soliciting a firm fixed price contract for the development of a Regulatory Science Tool for transcranial ultrasound modeling. The objective is to create a computational modeling package to simulate sonication protocols, standardize modeling techniques, and support regulatory review and patient safety. The scope of work includes performing validation and sensitivity analysis, developing baseline, best-case, and worst-case patient models, and establishing a standard reference tissue properties set. The contractor may utilize a single-technique or dual-technique approach, leveraging tools such as k-Wave or BabelViscoFDTD, to produce a software package compatible with Windows, Linux, and macOS. This unrestricted, simplified acquisition procurement is capped at 350,000 dollars with a performance period of 12 months from the date of award. To be eligible, the contractor's principal investigator must demonstrate significant expertise in TUS simulation through completed research projects or contributions to open-source tools. Award will be based on technical acceptability and a fair and reasonable price. The contractor must adhere to strict cybersecurity and privacy requirements, including the handling of Controlled Unclassified Information and the completion of mandatory HHS training. All deliverables will be inspected and accepted by the government at the destination.
General Info
Place of Performance
Silver Spring, MD, USASet-Aside
Timeline
Submission Closed
Organization & Contact Information
Full Description
Amendment 01 - Questions and Answers added to the documents section.
Regulatory Science Tool for Transcranial 1Ultrasound Modeling
see attached Solicitation
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