News

  • 830-8:40 AM ET
    Welcome /Objectives/Introductions, Semih Oktay, PhD

    840-9:00 AM ET
    Regulatory Considerations- FDA’s Role in Device Innovation, Semih Oktay, PhD
    Early Feasibility Study IDE
    Breakthrough Device Designation
    Safer Technologies Program

    9:00-9:45 AM ET
    Pre-clinical Bench Testing
    Latest ISO 5840 Part 1 and Part 3 updates, Ajit Yoganathan, PhD
    FDA expectations for EFS and pivotal IDE submissions, Jasmine Patel, PhD
    Insights gained from FDA interactions

    9:45-10:00 AM ET
    Pre-clinical In Vivo Studies
    Acute and Chronic In Vivo Studies, Stephen Hilbert, MD, PhD
    FDA expectations for EFS and pivotal IDE submissions,
    Wenda Carlyle, PhD and Victoria Hampshire, VMD
    Insights gained from FDA interactions

    10:30 -11:15AM ET
    Biocompatibility Testing, Wenda Carlyle, PhD
    Updates on FDA Guidance and ISO 10993
    Chemical characterization: Lessons learned from FDA interactions
    FDA expectations for EFS and pivotal IDE submissions
    Insights gained from FDA interactions

    11:15-12:00 PT ET
    Open panel discussion / Q&A

    Panel Members:
    Semih Oktay, PhD,
    Ron Waksman, MD
    Don Cutlip, MD
    Wenda Carlyle, PhD
    Daniel E. McLain, PhD
    Victoria Hampshire, VMD
    Stephen Hilbert, MD, PhD
    Ajit Yoganathan, PhD
    Jasmine Patel, PhD

  • Dr. Ajit Yoganathan joins the CardioMed Team
    June 1, 2020

    CardioMed Device Consultants is pleased to announce and welcome Dr. Ajit Yoganathan as a Principal Consultant with the firm. He is also an Emeritus Regents’ Professor and the Wallace H. Coulter Distinguished Faculty Chair in the Wallace H. Coulter Department of Biomedical Engineering at the Georgia Institute of Technology and Emory University, and a member of the National Academy of Engineering. Dr. Yoganathan’s 45+ year research career has been pioneering and translational in nature by applying basic engineering science to develop meaningful human health outcomes, specifically in the realm of cardiovascular engineering and biology His work utilizes experimental and computational biomechanical techniques to study native and artificial heart valves, structure function of the left and right sides of the heart, congenital heart diseases, and to develop minimally invasive cardiovascular interventions. He also uses non-invansive techniques such as laser Doppler velocimetry, digital particle image velocimetry, and Doppler ultrasound and magnetic resonance imaging to study and quantify blood flow physiology in the cardiovascular system, both on the bench and in vivo. Dr. Yoganathan also regularly works with medical device regulatory organizations. Since 1979, he has worked with the FDA and in 2004 he was appointed Chair of the International Standards Organization committee for implantable cardiovascular devices. During decades of research on heart valves, he has also worked with every manufacturer that has a replacement valve on the American market, including St. Jude Medical, Edwards Lifesciences, Medtronic, Carbomedics, Sorin Biomedical, and Boston Scientific, as well as with a number of smaller (including start-up) biomedical companies. Additionally, he consults with the major CV imaging companies, such as Philips, GE and Siemens. Since 1975, all prosthetic heart valves implanted in the U.S. – more than two dozen valve designs – have been studied and evaluated in Dr. Yoganathan’s lab. His detailed bio can be found on the CardioMed website at : www.cardiomedllc.com

  • EuroPCR 2019
    Palais des Congrès, Paris, France – May 21-24, 2019

    CardioMed Founder Dr. Semih Oktay will participate in the panel “Optimising the generation and regulatory application of clinical evidence in the European Union and the United States” to discuss changes in the pre-market and post-market regulatory process and different approaches to conduct efficient clinical research to support marketing approval in the United States. Please join Semih Oktay and the rest of the panel and session speakers on Wednesday May 22, 2019 1030-12:00pm in Room 252B for this stimulating discussion. To learn more about CardioMed Device Consultants, visit cardiomedllc.com or contact Jasmine Patel at jpatel@cardiomedllc.com. #EuroPCR

  • RAPS Regulatory Conference Europe 2019
    Brussels, Belgium – May 14-15, 2019

    Dr. Semih Oktay, President and Founder of CardioMed Device Consultants, is presenting in the session “Global Regulatory and Clinical Strategies: A New Paradigm for Integrated Product Design and Development” with Robin Stephens of Psephos Biomedical and Chao Xu of J MedTech. This session will be held on Tuesday, May 14th, 2019 at 11:00 AM and will address key elements that should be considered in developing appropriate global regulatory and clinical strategy for innovative new medical devices. Specifically, Dr. Oktay will present new FDA Medical Device initiatives, including Early Feasibility, Breakthrough Devices and Presubmission programs, as well as increasing patient engagement, and the development of National Evaluation System for Health Technology (NEST). Please contact Jasmine Patel at jpatel@cardiomedllc.com to schedule a meeting in Brussels.

  • CIT 2019 (China Interventional Therapeutics in partnership with TCT)
    Beijing, China, China National Convention Center (CNCC)

    Dr. Semih Oktay, President and Founder of CardioMed Device Consultants, and Dr. Roxana Mehran will be co-chairing and presenting at the CIT session “FDA Approval Pathway: Global Regulatory Considerations” on Thursday, March 28, 2019 5:00-6:30pm, where they and a panel of regulatory and industry experts will discuss the medical device approval processes in US and China, new programs at US FDA, preclinical testing strategies, and global clinical considerations. Visit CardioMed at booth #D062 in the Exhibit Hall to learn more about our regulatory and preclinical (bench, biocompatibility and animal) consulting services, clinical trial support, and US/European regulatory training programs in China. Please contact Dr. Jasmine Patel at jpatel@cardiomedllc.com to schedule a meeting with our team at CIT.

  • TCT 2018
    San Diego, CA – September 21-25, 2018

    Semih Oktay, President and Founder of CardioMed Device Consultants, will be a panel participant at the FDA Townhall Meeting on Sunday, September 23, 2018. In addition,
    CardioMed’s consultants Dr. Wenda Carlyle, Mr. Peter Carlyle, Dr. Jasmine Patel, Ms. Candace Cederman, and Dr. Lisa Bellincampi will be in attendance. Please contact Jasmine Patel at jpatel@cardiomedllc.com to schedule a meeting with our team in San Diego. #TCT2018

  • EuroPCR 2018
    Palais des Congrès, Paris, France – May 22-25, 2018

    Semih Oktay, President and Founder of CardioMed Device Consultants, will be a panel
    participant at the PCR Innovators Day Paris on Monday, May 21, 8:00-18:00. He is also
    chairing a session on Changes in Medical Device Regulation in Europe – What Every
    Interventionists Should Know on Tuesday, May 22, 2018, 13:45-15:15. In addition,
    CardioMed’s consultants Dr. Wenda Carlyle, Mr. Peter Carlyle, Ms. Mona Advani,
    and Dr. Lisa Bellincampi will be in attendance. Please contact us
    at info@cardiomedllc.com to schedule a meeting with our team in Paris. #EuroPCR

  • Transcatheter Cardiovascular Therapies (TCT) Scientific Symposium
    Denver, CO – October 29, 2017 – November 2, 2017

    Semih Oktay, President and founder of CardioMed Device Consultants, will be a panel participant at the TCT FDA Town Hall Discussions. CardioMed’s Principal Consultants Ms. Mona Advani, Dr. Wenda Carlyle, Mr. Peter Carlyle and Ms. Candace Cederman will also be in attendance at the TCT symposium. CardioMed consultants will be available to meet with anyone interested in discussing potential projects. Please contact us at info@cardiomedllc.com to schedule any such meetings with our team during the TCT Symposium. Access TCT website at http://www.crf.org/tct

  • US-Japan MedTech Frontiers
    Tokyo, Japan – Nov. 6, 2017
    Senior Corporate Executive Symposium

    Semih Oktay, President and founder of CardioMed Device Consultants, will participate as a panel member in the Session entitled “Ecosystem of International Collaboration for Innovative Medical Device Development.”

    This half-day symposium is for senior executives of Japanese medical device companies. It is designed to promote C-level collaboration through presentations by US MedTech executives, discussions of “disruptive” medical device start-ups, collaboration models and the sharing of innovative business models and commercialization scenarios. https://www.usjmf.net/
  • US – Japan MedTech Frontiers
    Okinawa, Japan – Nov. 8, 2017
    Fourth Annual Innovation Forum

    Semih Oktay, President and founder of CardioMed Device Consultants, will give a presentation and serve as a panel member in a Session entitled “Growing Asia’s Medical Device Industry through Innovation and International Collaboration.”

    This event is hosted by the Economy, Trade and Industry Department of the Okinawa Prefecture government, the Okinawa General Bureau Cabinet Office, the Government of Japan, and the National University of the Ryukyus Hospital.  This full-day conference is open to all members of the medtech industry. https://www.usjmf.net/

  • International Conference for Innovations in Cardiovascular Systems (ICI)
    Tel Aviv, Israel – December 3 – 6, 2017

    Semih Oktay, President and founder of CardioMed Device Consultants, will be in attendance
    at the ICI. Dr. Oktay will speak at the Academy of Innovation Day as well as serve as a
    Faculty member of the ICI. Dr. Oktay will also be available to meet with any interested party
    to discuss potential projects. Please contact us at info@cardiomedllc.com to schedule a
    meeting with Dr. Oktay at the ICI. Access ICI website at: http://2017.icimeeting.com/

  • Webinar – In collaboration with our partner organization QMed Consulting
    September 22, 2017

    Elisa D. Harvey, DVM, PhD, Principal Consultant at the CardioMed
    Device Consultants, gave a webinar on the “Basics of Clinical Trials for Medical Devices at
    FDA. This webinar covered how FDA’s regulations, processes and recommendations for
    clinical studies of medical devices in the US (whether they are for 510(k)s or PMAs),
    including significant and nonsignificant risk studies, early feasibility, feasibility and pivotal
    studies, use of clinical data from outside the US, and pre-submissions. To view this webinar,
    please click on the following link. View this webinar​