Notice of Intent to Sole Source: Tools to Validate Lung Ultrasound Protocols and Hardware for Use in Diagnosis of Pneumonia and Cardiac Complications of COVID-19 Infection

This is a Notice of Intent to Sole Source. The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to Siemens Medical Solutions USA, Inc. The Government intends to issue a sole source award in accordance with FAR 6.302-1, only one responsible source and no other will satisfy the agency requirements for the above stated service. The FDA is currently working to develop tools and procedures for quantifying the percentage of lung covered by lung ultrasound (US) examinations, a new application heavily used to evaluate COVID-19 patients for extent of COVID-related viral pneumonia. To achieve our goals existing CT-US fusion software on the recently acquired FDA Siemens Sequoia shall be modified to allow capture of cine clips containing CT images with an overlay of the location of the ultrasound beam. This data shall then be reconstructed into 3D volumes that can be manipulated to visualize what parts of the lung are covered by the ultrasound beam and to calculate the percentage of the lung volume covered by the ultrasound beam. The software shall run on the current FDA Sequoia US system, model #1114875 software revision VA11F or higher, including the 3D positioning system (Ascension Technology) already procured from Siemens as an option for the Sequoia.