Post-Market Medical Device Surveillance With a Novel mHealth Platform

  • Overview

    The project tested the feasibility of using a mHealth app for post-market surveillance in patients (1) after sleeve gastrectomy and (2) after catheter-based atrial fibrillation ablation. Outcomes collected included enrollment times, patient participation, dropout, completion of patient-reported outcome measure queries, and user satisfaction and burden. This study enrolled 60 patients at Yale New Haven Hospital and Mayo Clinic.

    The manuscript for this Demonstration Project was published in npj Digital Medicine on April 20, 2020.

    Read an overview of the study on the NESTcc Blog.

  • Impact for NESTcc

    The systematic process used to test and validate the mHealth app and assess its feasibility of use will provide insight and produce a framework for future use of mHealth apps in the post-market setting. Learnings will be extendable to pre-market evidence generation use-cases in the future.

  • Organizations

    Johnson & Johnson, U.S. Food and Drug Administration (FDA), Me2Health, Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI)

  • Principal Investigators

    Joseph Ross, MD, MHS, Yale and Nilay Shah, PhD, Mayo

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