Inactive Total Small Business Set-Aside (FAR 19.5)

The Optical Diagnostics Laboratory (ODD), a division within the Division of Biomedical Physics (DBP) performs research on novel optical imaging systems. Current projects focus on evaluating performanc... The Optical Diagnostics Laboratory (ODD), a division within the Division of Biomedical Physics (DBP) performs research on novel optical imaging systems. Current projects focus on evaluating performance of near infrared spectroscopy (NIRS) and photoacoustic imaging (PAI) systems used to measure blood Oxygen Saturation (SO2). A critical need for these projects is a device that provides clinically relevant "gold standard" measurements of SO2 in situ within tissue phantoms or small animals. A suitable device would be a compact minimally invasive catheter probe based on optical sensing. The device should be a well-validated system that is capable of accurately measuring absolute blood oxygen saturation levels. This need for the ODD can be fulfilled by purchasing a hemodynamics and oximetry monitoring system. A hemodynamics and oximetry monitoring system directly measures blood pressure from inside the veins, heart and arteries. They also measure blood flow and how much oxygen is in the blood. In addition, these systems have interfaces to help document diagnostic catheterizations, coronary, peripheral and electrophysiology (EP) procedures. The most common types of invasive hemodynamic monitors are central venous catheters, pulmonary artery catheters, and arterial pulse-wave analysis. This collaboration between OSEL and DBP will support the Center for Devices and Radiological Health (CDRH)’s mission in the development of studies and new development in medical technologies that identify abnormal physiology in measurements of blood pressure from inside the veins, heart and arteries which identify abnormal physiology and intervene before complications that can lead to organ failure and death.