Dr. Ksenia Blinova, Ph.D., is the Associate Director for the Division of Applied Regulatory Science at the U.S. Food and Drug Administration, where she leads innovative research, regulatory reviews, and scientific consultations that advance translational science in support of public health. With a strong academic foundation in physics, mathematics, and cardiac electrophysiology, she has built a distinguished career focused on bridging fundamental science with regulatory applications. Since joining the FDA as a Commissioner’s Fellow, Dr. Blinova has held key leadership roles, including Deputy Director of the Division of Biomedical Physics, where she led multidisciplinary teams in developing over forty regulatory science tools that improved the evaluation of medical devices across fields such as cardiology, neurostimulation, diagnostics, and patient monitoring. Her career reflects a unique combination of scientific excellence, leadership, and commitment to advancing safe and effective medical products, making her an influential figure in the field of regulatory science.
Professional Profile
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Education
Dr. Ksenia Blinova earned her undergraduate and doctoral degrees in Physics and Mathematics from Moscow State University, where she developed a strong foundation in quantitative sciences and analytical problem-solving. She further advanced her academic journey through a postdoctoral fellowship at the National Heart, Lung, and Blood Institute at the National Institutes of Health. Her research during this period centered on cardiac electrophysiology and metabolism, areas that deepened her expertise in biomedical applications of physical sciences. This educational trajectory not only equipped her with advanced technical knowledge but also gave her a unique interdisciplinary perspective that integrates rigorous physics and mathematical methodologies with life sciences and clinical research. Her educational background has been pivotal in shaping her ability to address complex regulatory and scientific challenges, contributing to her capacity for innovation and leadership in translational science and regulatory policy at the intersection of medicine, technology, and public health.
Experience
Dr. Blinova has built a distinguished career at the U.S. Food and Drug Administration, beginning as a Commissioner’s Fellow and progressing to influential leadership roles. As Deputy Director of the Division of Biomedical Physics in the Center for Devices and Radiological Health, she guided a multidisciplinary team in creating innovative regulatory science tools that addressed critical challenges in medical device safety and effectiveness. Her leadership was instrumental in developing methods and resources for fields such as cardiology, neurostimulation, ophthalmology, in-vivo diagnostics, and advanced patient monitoring. Currently serving as Associate Director for the Division of Applied Regulatory Science in the Office of Clinical Pharmacology, she oversees research, scientific consultations, and regulatory reviews that support the FDA’s translational science priorities. Through these roles, she has combined her technical expertise with strategic vision, ensuring that scientific advancements translate into practical regulatory applications that safeguard patient health and promote medical innovation.
Research Focus
Dr. Blinova’s research focuses on advancing translational and regulatory science to accelerate the safe and effective delivery of medical products to patients. Her early work in cardiac electrophysiology and metabolism provided insights into fundamental mechanisms of heart function, laying the groundwork for her later contributions in biomedical physics and device evaluation. At the FDA, she has led research efforts that integrate computational modeling, experimental studies, and regulatory tool development to address complex safety and efficacy challenges in medical devices and drug-device combinations. Her team has developed innovative approaches to evaluate technologies in cardiology, neurostimulation, electrical safety, diagnostics, and patient monitoring, ensuring that regulatory science keeps pace with rapid technological advances. By bridging basic science, applied research, and policy, her work exemplifies the role of regulatory science in translating innovation into tangible benefits for patients and healthcare systems, while maintaining a focus on safety, effectiveness, and public health impact.
Award and Honor
Throughout her career, Dr. Blinova has been recognized for her leadership, innovation, and contributions to regulatory science. Her accomplishments include guiding the development of over forty regulatory tools that have had a lasting impact on how medical devices are assessed for safety and effectiveness. These achievements reflect not only her scientific expertise but also her ability to collaborate across disciplines to solve pressing healthcare challenges. Her recognition within the FDA and broader scientific community underscores her role as a leader who consistently advances the field of translational science. Honors and awards in her career highlight her success in bridging science and regulation, her dedication to patient safety, and her influence in shaping modern approaches to medical product evaluation. These distinctions serve as a testament to her sustained contributions, her commitment to innovation, and her growing impact as a respected figure in regulatory and biomedical research.
Publication Top Notes
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Title: Nonclinical Human Cardiac New Approach Methodologies (NAMs) Predict Vanoxerine-Induced Proarrhythmic Potential
Authors: M. Iveth Garcia, Bhavya Bhardwaj, Keri Dame, Verena Charwat, Brian A. Siemons, Ishan Goswami, Omnia A. Ismaiel, Sabyasachy Mistry, Tromondae K. Feaster, Kevin E. Healy, et al.
Year: 2025
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Title: In Vitro Assay Development to Study Pulse Field Ablation Outcome Using Solanum Tuberosum
Authors: Akshay Narkar, Abouzar Kaboudian, Yasaman Ardeshirpour, Maura Casciola, Tromondae Feaster, Ksenia Blinova
Year: 2024
Citations: 2
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Title: Nonclinical evaluation of chronic cardiac contractility modulation on 3D human engineered cardiac tissues
Authors: Tromondae K. Feaster, Jourdan K. Ewoldt, Anna Avila, Maura Casciola, Akshay Narkar, Christopher S. Chen, Ksenia Blinova
Year: 2024
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Title: Comprehensive Collection of Current Methods for Contractility and Electrophysiology Recordings in Human Cardiac Cells
Authors: Ksenia Blinova, J. Pierson, A. Narkar
Year: 2023
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Title: Human in vitro assay for irreversible electroporation cardiac ablation
Authors: Maura Casciola, Tromondae K. Feaster, M. J. Caiola, D. Keck, Ksenia Blinova
Year: 2023
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Title: Acute effects of cardiac contractility modulation stimulation in conventional 2D and 3D human induced pluripotent stem cell-derived cardiomyocyte models
Authors: Tromondae K. Feaster, N. Feric, I. Pallotta, A. Narkar, M. Casciola, M. P. Graziano, R. Aschar-Sobbi, Ksenia Blinova
Year: 2022
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Title: Evaluation of Cardiac Contractility Modulation Therapy in 2D Human Stem Cell-Derived Cardiomyocytes
Authors: Tromondae K. Feaster, Maura Casciola, Akshay Narkar, Ksenia Blinova
Year: 2022
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Title: Human in vitro neurocardiac coculture (iv NCC) assay development for evaluating cardiac contractility modulation
Authors: Akshay Narkar, Tromondae K. Feaster, Maura Casciola, Ksenia Blinova
Year: 2022
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Title: Human cardiomyocytes are more susceptible to irreversible electroporation by pulsed electric field than human esophageal cells
Authors: Maura Casciola, Devin Keck, Tromondae K. Feaster, Ksenia Blinova
Year: 2022
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Title: Chronic Cardiotoxicity Assays Using Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes (hiPSC-CMs)
Authors: Akshay Narkar, James M. Willard, Ksenia Blinova
Year: 2022
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Title: Cardiovascular medical devices: Regulatory science research overview in the office of science and engineering laboratories (OSEL) at the food and drug administration (FDA)
Authors: K. Aycock, Ksenia Blinova, M. Casciola, B. Craven, M. Di Prima, G. D’Souza, N. Duraiswamy, M. Farahmand, P. Hariharan, L. Herbertson, et al.
Year: 2021
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Title: Acute effects of cardiac contractility modulation on human induced pluripotent stem cell–derived cardiomyocytes
Authors: Tromondae K. Feaster, Maura Casciola, Akshay Narkar, Ksenia Blinova
Year: 2021
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