CDRH-2024-122752-Add-on SenoBright HD with Nira IQ suite software for GE Pristina FFDM/DBT System.

The U. S. Food & Drug Administration, (FDA) Office of Acquisition and Grants Services (OAGS) has a requirement to procure a CDRH-2024-122752-Add-on SenoBright HD with Nira IQ suite software for GE Pristina FFDM/DBT System under Solicitation: FDA-RFQ-CDRH-2024-122752.

The objective of the requirement is to procure the contrast-enhanced mammography software (SenoBright HD with Nira IQ suite) for the GE Senographe Pristina mammography system that will allow FDA researchers to develop and compare new methods for testing performance for this mode of mammography system. The end result of this requirement if the contract is successful will be the development of new approaches for objectively assessing image quality of contrast mammography systems.

These new testing methods could potentially reduce the burden of sponsors that submit new technology to the FDA for approval and accelerate the introduction of new contrast mammography breast imaging products to the general public. New testing methods will be published as an OSEL regulatory science tool. See the attached RFQ for a response.