Podcast #8: A Leap Forward In Cardiology: The Catheter Poised To Change Heart Disease Treatment
It is common knowledge that the United States Food and Drug Administration oversees the safety of the food supply and the approval of effective and safe new drugs. It is not as widely known that the same FDA also oversees the efficacy and safety of new medical devices and that there is a facilitated pathway to get these devices to the marketplace called the 510(k) pathway that has been used over 100,000 times.
Please join us as we discuss with Dr. Philipp Raschendorfer, Chief Scientific Officer of Intravascular Imaging, i3, how he developed a new, better catheter to evaluate and help treat coronary artery disease and what he had to do to get the device ready for FDA approval.
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