Related Experiment Video
Updated: Feb 7, 2026

Author Spotlight: Alleviating Nausea and Vomiting in Pregnancy with Safe and Effective Auricular Acupuncture
Published on: August 4, 2023
Safety and Effectiveness of Medical Device Therapy
1Division of Applied Regulatory Science, U.S. Food and Drug Administration, Silver Spring, MD, USA. robbert.zusterzeel@fda.hhs.gov.
Abstract:
When enough females and males are enrolled in clinical trials, much more relevant information is available on potential sex differences in device safety and effectiveness. Unfortunately, females have largely been underrepresented in clinical studies of cardiac medical device therapies for heart failure. In this chapter, sex differences in heart failure characteristics and cardiac electrophysiology and their influence on the safety, effectiveness, and application of implantable cardioverter defibrillators (ICDs), subcutaneous ICDs (S-ICDs), and cardiac resynchronization therapy (CRT) will be discussed. In this way, the research community will hopefully become more appreciative of the potential differences in device effects between females and males.
More Related Videos
05:56Evaluation of the Feasibility, Safety, and Accuracy of an Intraoperative High-intensity Focused Ultrasound Device for Treating Liver Metastases
Published on: January 9, 2019
07:24Development of an Innovative LED-based Illumination Device for In Vitro Application of Photodynamic Therapy with Rose Bengal
Published on: September 12, 2025
Related Concept Videos
Survey Safety
Gene Therapy
Inhaled Medications
Household Wiring And Electrical Safety
Biological Effects of Radiation
Group Therapy