News

Semih Oktay, President and Founder of CardioMed Device Consultants, will be a panel participant at the following sessions:
Sunday Sept 18 at 2pm DCB Studies II and Monday Sept 19 at 8:36 am Newer DES II
Please contact us at jpatel@cardiomedllc.com to schedule a meeting with our team in Boston. Look forward to seeing you at #TCT2022

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

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

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

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.

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.

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

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

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

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/

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/

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​