AI/ML Model Development for Cardiovascular Simulation

The contract seeks the development and validation of artificial intelligence and machine learning models aimed at enhancing the reliability and reproducibility of computational simulations used to evaluate cardiovascular devices. The work will focus on creating robust AI/ML systems that improve the accuracy and consistency of simulation outcomes, ensuring that these tools can be trusted for regulatory and clinical decision-making. The project is critical for advancing the use of digital twins and virtual testing environments in the assessment of cardiovascular implants and interventions, ultimately supporting safer and more effective medical device innovation. This subcontract is issued under the NAICS code 541715 for scientific research and development services by the FDA Office of Acquisition and Grant Services within the Department of Health and Human Services. The solicitation was posted on July 28, 2026, with a response deadline of August 7, 2026. While no set-aside designation or location details are specified, the work is expected to be performed remotely or wherever the contractor’s capabilities are located. Participation requires expertise in computational modeling, biomedical data science, and regulatory-compliant validation methodologies, with the goal of producing models that meet the stringent standards needed for FDA-relevant device evaluation.