Inactive Total Small Business Set-Aside (FAR 19.5)

The Ultrasound Program within the Division of Applied Mechanics (DAM), Office of Science and Engineering Laboratories (OSEL), CDRH, and the U.S. Food and Drug Administration (FDA) would like to purcha... The Ultrasound Program within the Division of Applied Mechanics (DAM), Office of Science and Engineering Laboratories (OSEL), CDRH, and the U.S. Food and Drug Administration (FDA) would like to purchase a state-of-the-art, tomographic microscope to: (i) characterize the behavior of cells, single and populations of cells, and cells in static and flow-based conditions before, during, and after ultrasound treatments, (ii) simulate flows in the ibidi compatible devices for the vasculature- and neuro-systems, (iii) study bubble collapse dynamics affects for ultrasound applications, such as the opening the Blood- Brain Barrier, neuromodulation, or ablation of tissue, and (iv) evaluate the interactions between physiological static and flows for ultrasound medical procedures. This equipment will help CDRH understand complex cellular mechanics and device- and treatment- related complications in the ultrasound diagnostic and therapeutic spaces. The system should have special features such as holography and rotational scanning to allow the user to understand the detailed effects of ultrasound treatment on cells in their native environment without human error: label-free, non-invasive, manipulation-free, and interference-free. The microscope needs to have the capability for a built-in incubator that will enable long-term stainless imaging of cellular studies in a well-controlled environment, a capability that the FDA’s ultrasound program does not currently possess. The laser-based system for tomographic imaging allows imaging of cells in small time increments for overnight studies to capture every movement of the cell without any phototoxicity. The features of the microscope will enhance the Center’s scientific capabilities and support efforts to effectively evaluate emerging technologies such as Blood-Brain Barrier applications, neuromodulation and bubble dynamic effects on cells for medical ultrasound procedures. Additionally, the researchers must be provided training, technical and customer support, updates and warranty as outlined in the specifications. **See attachment Solicitation_1243439.pdf for full Solicitation