About The Center for Medical Devices
The Center for Medical Devices (CMeD), part of Mount Sinai Heart, was first launched in 2014 with Mount Sinai's recruitment of leading cardiac expert Julie Swain, MD. Dr. Swain is an experienced cardiothoracic surgeon with more than twenty-five years experience practicing cardiac surgery and more than two decades of additional experience as an advisor to the FDA where she served as a clinical trials expert for medical device evaluation.
Dr. Swain joins forces with Mount Sinai Heart's internationally acclaimed leadership team including David Adams, MD, Chairman of the Department of Cardiothoracic Surgery, and Valentin Fuster, MD, PhD, Director of Mount Sinai Heart and Physician-in-Chief at The Mount Sinai Hospital.
Together, the leadership team leverages its clinical expertise with its in-depth knowledge and vast experience in all aspects of advanced clinical trial design, medical device testing, and the regulatory approval process. Their combined know-how and proven track-record of success will now be shared to help medical device developers accelerate their device's preclinical and clinical trial testing and potential approval of their devices.
Consultation services available through the CMeD include medical device assessment and evaluation, regulatory approval strategies, advanced clinical trial design, data interpretation, FDA submissions, and access to research facilities and potential clinical testing of devices within the Mount Sinai Health System.
In addition, CMeD will be a training center for future medical personnel wishing to gain experience in advanced clinical trial design and evaluation of medical devices. Learn more about CMeDs available services.
Center for Medical Devices
Mount Sinai Heart
Icahn School of Medicine at Mount Sinai
One Gustave L. Levy Place, Box 1028
New York, NY 10029-6574