MDIC releases first of three resources that will be part of its Framework for Patient Input in Medical Device Clinical Trials
MDIC is seeking public comments on its Best Practices for Communicating Benefit, Risk and Uncertainty white paper in support of the Framework for Patient Input in Medical Device Clinical Trials that is set to be complete next year. MDIC’s Science of Patient Input Steering Committee has worked to understand the best methods to assess patient […]
MDIC Releases IVD Clinical Evidence Framework
MDIC’s Clinical Diagnostics Program today released the Framework for Developing Clinical Evidence for Regulatory and Coverage Assessments in In Vitro Diagnostics. This Framework is intended to help test sponsors make decisions on how to develop credible evidence of analytical and clinical validity and clinical utility. It is a product of MDIC’s IVD Clinical Evidence Working […]
CVRx President and CEO Nadim Yared Named Chairman of the MDIC Board of Directors
MDIC announced today that CVRx’s President and CEO Nadim Yared has been named chairman of the MDIC Board of Directors and Executive Committee for a two-year term. Yared has served on the MDIC Board of Directors since 2013. He will succeed Abiomed President and CEO, Michael Minogue who will remain on the Board. Read the […]
MDIC Releases 2018 Annual Report
MDIC is excited to announce the release of our first annual report and share the impact of our work during the 2018 year. This report not only helps quantify and demonstrate the impact we’ve had but also helps us identify opportunities for growth and improvement. Some of the key highlights from the Annual Report include […]
NESTcc Announces 12 New Real-World Evidence Test Cases
Today, NESTcc announced 12 new Real-World Evidence (RWE) Test-Cases. These projects will answer questions of importance to the medical device ecosystem through collaborations between NESTcc Network Collaborators and submitting organizations, including health systems, government organizations, non-profit patient organizations, and medical device manufacturers. NESTcc’s Test-Case portfolio now includes 20 projects that span the Total Project Life […]
MDIC Seeks Comments on Draft List of Prioritized Tumor Suppressors
MDIC’s Clinical Diagnostics Cancer Genomic Somatic Reference Samples working group seeks public comments on the draft list of prioritized tumor suppressors. The goal of the initiative is to develop reference samples that can be made available to the public to improve the accuracy, reliability and transparency of Next-Generation-Sequencing (NGS) based oncology tests. In addition, the […]
MDIC Holds External Evidence Methods Executive & Fellows Meeting
On April 2, 2019, MDIC’s External Evidence Methods (EEM) program hosted an Executive & Fellows meeting with about 70 subject matter experts from FDA, industry, and non-profit organizations to discuss the existing methods and identify gaps for the use of external data. MDIC’s EEM program aims to establish a more predictable pathway for use of external […]
MDIC Releases RFI on Creating Human Cell Lines
MDIC released a Request for Information (RFI) on March 30, 2019. We are requesting technical information about available and possible approaches for creating a set of human cell lines that include all–or subsets of– specific variants. The variants were drawn from a larger list developed by the MDIC SRS working group and include clinically actionable […]
MDIC to Release RFI on Creating Human Cell Lines
MDIC will release a Request for Information (RFI) on March 30, 2019. We are requesting technical information about available and possible approaches for creating a set of human cell lines that include all–or subsets of– specific variants. The variants were drawn from a larger list developed by the MDIC SRS working group and include clinically […]
