Global Regulatory Perspectives on Pediatric Electrophysiology Device Development

Description

In this session, we will discuss various global perspectives on pediatric EP device regulation, including ablation technologies and CIEDs. With the regulatory changes in the European Union and US Food and Drug Administration, there have been interesting shifts in how these technologies can obtain clearance and reach the commercial market for this vulnerable population. A joint session with Pediatric and Congenital Electrophysiology Society (PACES).

Learning Objectives

Compare regulatory processes from around the world.
Summarize how the regulatory processes are similar around the world.
Discover ways that the pediatric EP community can work together around the world to help in the regulatory process.

Session Chair(s)

Jennifer Silva, MD
Yaniv Bar-Cohen, MD

Presentation

Panel Discussion
Presenter(s): Andreas Pflaumer, MD

Panel Discussion
Presenter(s): Gabriele Hessling, MD

Panel Discussion
Presenter(s): Anne M. Dubin, MD

Panel Discussion
Presenter(s): Muhammad Mohsin, MBBS

Panel Discussion
Presenter(s): Jan Janousek, MD, PhD

Disclosures

Andreas Pflaumer:

Navi medical systems (Stock Options – Privately Held (including start-up companies) - Membership on Advisory Committees or Review Panels)

Gabriele Hessling:

Nothing Relevant to Disclose

Anne Dubin:

UpToDate, Inc. (Royalty Income - royalty for article)

Muhammad Mohsin:

Nothing Relevant to Disclose

Jan Janousek:

Abbott Medical (Honoraria/Speaking/Consulting Fee - Speaking and Teaching)

To view all Heart Rhythm 2025 Faculty Disclosures, please click here.

Summary


Availability:	No future session


Cost:	FREE


Credit Offered:	No Credit Offered