SaMD based cardiovascular diagnostic device (ppg and ecg wearables)
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The contract involves engaging an external contractor to collaborate on the development of benchmark reference datasets specifically designed for validating and supporting algorithm development related to a Software as a Medical Device (SaMD) focused on cardiovascular diagnostics. This SaMD utilizes photoplethysmography (PPG) and electrocardiogram (ECG) wearable technologies to monitor cardiovascular health. The project aims to ensure the accuracy and reliability of these diagnostic devices through comprehensive dataset creation. This opportunity, forecasted by the Food and Drug Administration (FDA), falls under the NAICS code 541714, which pertains to research and development in the physical, engineering, and life sciences. While specific location details for the contract performance and solicitation number are currently unspecified, the FDA will oversee the contract management, with designated points of contact available for inquiries. The initiative highlights the agency's commitment to advancing innovative medical device technologies through rigorous validation standards.
General Info
Agency
NAICS
Place of Performance
USSet-Aside
Documents
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