David Ikeda

David Ikeda brings over 35 years of experience in the medical device and in vitro diagnostics industries to his role as Sr. Director, Clinical Operations and Regulatory Strategist at CovarsaDx.

At Beckman Coulter, David led global regulatory functions supporting the blood virus program development team. He has played an instrumental role in launching multiple products through clinical trials, registration efforts, and post-market quality processes. His notable achievements include bringing blood virus and infectious disease tests to worldwide markets, along with significant contributions to therapeutic areas such as bone and mineral metabolism, cancer oncology, glucose/HbA1c, and urine chemistry.


David’s expertise includes FDA and EU submissions for the IVD industry, such as 510(k), premarket approval (PMA), PMA supplements, annual reports, and Class D IVDR dossiers. His accomplishments have empowered organizations to maintain rigorous quality standards while optimizing operational efficiency.


He received his Bachelor of Science in Chemistry from Haverford College and graduate training in Biochemistry from the University of Minnesota.