The Center for Medical Devices (CMeD) provides regulatory strategy and clinical trial design assistance and services for companies seeking the U.S. Food and Drug Administration’s (FDA) approval for cardiovascular medical devices. By sharing our expertise with companies and medical device inventors, CMeD helps researchers further develop technologies, design clinical trials, and test medical devices in an advanced clinical trial environment.
Our leadership effectively leverages the clinical expertise of the Center’s diverse team and our academic medical center’s expertise in cardiology and cardiovascular surgery. CMeD’s particular interest in cardiovascular medical devices stems from our team’s combined know-how and proven track record of success helping developers accelerate preclinical and clinical trial testing and expedite prospective approval of leading-edge medical devices.
The Mount Sinai Center for Medical Devices can provide effective guidance and preparation for many different interactions with FDA and Investigational Device Exemption (IDE) approval, including:
- Beginning the FDA medical devices approval process
- Seeking FDA approval for a cardiovascular device
- Seeking approval in the United States by an international company
- Seeking IDE approval
- Evaluating data for a final submission to obtain FDA approval
Our consultation services include device assessment and evaluation, strategies for securing regulatory approval and navigating the FDA submissions process, advanced clinical trial design, data interpretation, access to research facilities, and potential clinical testing of devices within the Mount Sinai Health System.