Patients with Parkinson’s Disease Help to Shape Clinical Trial Design

Patients with Parkinson’s Disease Help to Shape Clinical Trial Design

Patients with Parkinson’s Get Their Say on Device Trial Design

Patients with Parkinson’s Get Their Say on Device Trial Design The first-of-its-kind research collaboration between the Medical Device Innovation Consortium, The Michael J. Fox Foundation, FDA, and others is one step closer to designing trials with significance levels that dial in patient preferences.

An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials

An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials, The New England Journal of Medicine

CDRH Plots Path to New ‘Progressive’ Approvals for Some Devices

CDRH Plots Path to New ‘Progressive’ Approvals for Some Devices

Computer-Based Modeling, Pathways To Faster FDA Approval

Computer-Based Modeling, Pathways To Faster FDA Approval

MDIC Announces Rachael L. Fleurence, Ph.D. Appointed as Executive Director of the National Evaluation System for health Technology Coordinating Center (NESTcc)

MDIC Announces Rachael L. Fleurence, Ph.D. Appointed as Executive Director of the National Evaluation System for health Technology Coordinating Center (NESTcc)

The Center for Devices and Radiological Health (CDRH) 2016-2017 Strategic Priorities – 2016 Accomplishments

The Center for Devices and Radiological Health (CDRH) 2016-2017 Strategic Priorities – 2016 Accomplishments

National Evaluation System for health Technology Coordinating Center

Following the receipt of $3 million in FDA seed funding, MDIC has begun operationalizing the Coordinating Center for the Medical Device National Evaluation System for health Technology (NEST). The Coordinating Center will strategically promote responsible sharing and efficient analysis of real-world evidence to inform and empower patients, accelerate medical device innovation, and improve healthcare outcomes. Learn […]

Incorporation of stochastic engineering models as prior information in Bayesian medical device trials

MDIC Virtual Patient Statistical Framework publication published: “Incorporation of stochastic engineering models as prior information in Bayesian medical device trials” Congratulations to the MDIC Computer Modeling and Simulation team in developing this work and the Clinical Trial Science team for operationalizing it!