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FDA Regulation of Cardiovascular Devices and Opportunities for Improvement
This article reviews FDA regulation of cardiovascular devices and offers suggestions for strengthening the process while focusing on examples relevant to cardiac electrophysiologists.
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Predictive Value of Perioperative Near-Infrared Spectroscopy for Neurodevelopmental Outcomes after Cardiac Surgery in Infancy
The study objective was to expand on prior research examining intraoperative regional cerebral oxygen saturation (rSO(2)) measured by near-infrared spectroscopy (NIRS) by evaluating the predictive value of perioperative NIRS monitoring for neurodevelopmental outcomes after infant cardiac surgery.
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Hemodilution Increases the Susceptibility of Red Blood Cells to Mechanical Shear Stress During In Vitro Hemolysis Testing
Hemodilution with BSA maintains protein concentration within a physiologic range and reduces bias during hemolysis testing at high blood dilutions. Thus, American Society for Testing and Materials standards could consider including BSA as a diluent, when and as required: where large dilution is required (<83%) use PBS + 4 g% BSA, otherwise use PBS alone.
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