AI/ML and Data Analytics for Cardiovascular Device Validation

The contract involves supporting the validation of an FDA-developed ECG signal transformation framework using artificial intelligence and machine learning techniques, with a focus on algorithm testing and performance benchmarking across both clinical and synthetic datasets. The work is part of a broader effort to enhance the accuracy and reliability of cardiovascular device evaluation through advanced data analytics, requiring expertise in signal processing, machine learning model development, and rigorous validation methodologies to ensure regulatory compliance and scientific rigor. This subcontract is issued under the NASAICS code 541714 by the FDA Office of Acquisition and Grant Services, part of the Department of Health and Human Services, with performance expected to take place in Silver Spring. The opportunity was posted on July 21, 2026, with a response deadline of July 28, 2026, at 6:00 PM, indicating a narrow window for submission. Interested parties must be prepared to demonstrate technical capability in handling sensitive biomedical data, applying robust AI/ML approaches to medical signals, and delivering precise benchmarking results that align with FDA’s validation standards for cardiovascular devices.