Collaboration Details

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Title of Collaborative Activity:

NIH-FDA Medical Device Research Interest Group and Medical Imaging and Data Resource Center (MDRIG)

Description of Collaborative Activity:

The Medical Device Research Interest Group (MDRIG) meets quarterly to share information and ideas on supporting research throughout the development pipeline. Recent topics of interest include medical device clinical innovation and translation efforts, artificial intelligence and machine learning in imaging, early feasibility supplement for the Small Business Innovation Research (SBIR) grantees that would facilitate grantee Food and Drug Administration (FDA) meetings and communication in the formative years to increase appropriate planning during the development of their technologies toward FDA approval, and device digital twin technologies. Supported by NIBIB, MDRIG continues to meet four times per year.;In 2018, NIBIB hosted a trans-NIH workshop on gadolinium retention in patients after magnetic resonance imaging. Collaborators included the extramural medical imaging community. A subsequent widely referenced white paper identified gaps in knowledge and future areas for research. This workshop included FDA participation.;NIBIB also funded and hosted two large workshops on AI in Medical Imaging that included the FDA ; CMS and a wide swath of the extramural medical community. One was held in August 2018 and another in November 2019. These meetings also included NSF and NIST. In August 2020, NIBIB contracted the Medical Imaging ; Data Resource Center (MIDRC), which includes close FDA collaboration, in a project to aggregate medical images and develop AI-ready data and AI/ML algorithms for helping with the clinical management of COVID-19 patients and the pandemic in general.;As of this date, over 30,000 highly curated AI-ready COVID images are already available for public access and investigation, over 200,000 more are in the pipeline, and 24 algorithms are under development. An internal NIH advisory board monitors MIDRC along with NIBIB.

Type of Collaborative Activity:

Committee, Advisory Group, or Work Group

Year the Collaborative Activity Originated:

2016

NIH Participating Institutes/Centers/Office of the Director:

NCATS, NCI, NEI, NHLBI, NIA, NIAID, NIBIB, NICHD, NIDDK, NINR, OD/DPCPSI/ORIP, FIC, NIAMS, NIDA

HHS Agency Collaborators on this Activity:

CMS, FDA