Background
Dr. Kazmierski specializes in developing and refining strategy for Cardiovascular Monitoring and Implantable Electrophysiology devices intended to treat Heart Failure. He has extensive experience navigating the complex predicate landscape within the cardiac diagnostics space, especially AI algorithms for patient monitoring or disease prediction as well as heart failure diagnosis and monitoring. He specializes in devices for both therapeutic devices such as active implantable heart failure devices and for diagnostics such as “cuffless” blood pressure monitors, multiparameter monitors, cardiovascular disease indicators relying on AI algorithms, heart failure diagnostic devices, and more.
Education
Dr. Kazmierski received a B.S.E. in Biomedical and Electrical Engineering from Duke University and a Ph.D. in Biomedical Engineering from Johns Hopkins University.
Experience
Dr. Kazmierski worked for over 10 years in the Division of Cardiovascular Electrophysiology, Diagnostics, and Monitoring within the Office of Cardiovascular Devices at FDA. While there, he began his regulatory work leading the review of several heart failure and electrophysiology trials for implantable devices prior to becoming Team Lead in the Implantable Electrophysiology Devices Team. He then moved to diagnostic devices in the cardiovascular device space where he served as Team Lead and Acting Assistant Director for the Hemodynamic and Heart Failure Diagnostics Team, overseeing a diverse area of devices including pressure catheters, implantable hemodynamic monitors, intensive care unit monitoring algorithms, “cuffless” blood pressure devices, as well as several software algorithms intended to identify at-risk patients using available electronic medical record data. Because of the rapid growth of these devices areas, Dr. Kazmierski also served on multiple working groups within FDA including the TPLC Advisory Program working group, the Artificial Intelligence Guidance Development working group, and Early Feasibility Study working group.
Overview
Dr. Kazmierski supports regulatory strategy and submissions. His primary roles include managing the development of regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies with clients.