Archive - Jan 2015 - SCA Article

Archive - Jan 2015 - SCA Article

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January 29th

Webinar on FDA Automated External Defibrillators Final Order - February 5

Summary: On January 28, 2015, the FDA issued a final order that required manufacturers of automated external defibrillators to submit premarket approval applications (PMAs) in order to market their products. This action requires a more rigorous review of these devices, which will ultimately help improve their reliability. In addition, the FDA will also require premarket approval for critical AED accessories, such as batteries and pad electrodes.

January 28th

Federal Register: Effective Date of Requirement for Premarket Approval for AED Systems

The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use). More...

Public Comments in Response to Proposed Order

January 27th

FDA Takes Steps to Improve Reliability of Automated External Defibrillators

The U.S. Food and Drug Administration announced today that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices.

The FDA issued a final order that will require AED manufacturers to submit premarket approval applications (PMAs), which undergo a more rigorous review than what was required to market these devices in the past. The agency’s strengthened review will focus on the critical requirements needed to ensure the safety and reliability of AEDs and their necessary accessories, including batteries, pad electrodes, adapters and hardware keys for pediatric use.

January 15th

Sudden Cardiac Arrest, A Public Health Crisis, Affects Nearly 1,000 People Each Day in the U.S.

The Sudden Cardiac Arrest Foundation highlights information from a new report indicating that 326,200 people experience sudden cardiac arrest outside hospitals annually in the U.S., including thousands of children. On average, only one in 10 victims survives; when bystanders witness the emergency, however, one in three victims survives.

January 7th

SCA Survivor Fashion Show Set for Mall of America

The Sudden Cardiac Arrest Foundation is inviting female sudden cardiac arrest (SCA) survivors who live in the Minneapolis/St. Paul area to participate in a Feb. 7 fashion show at the Mall of America. "We are looking for women who would be willing to put a face on heart disease/sudden cardiac arrest," the foundation stated in a Jan. 6 tweet that asked those who are interested in taking part to send an email to info [at] sca-aware [dot] org.

Mary Newman, MS, the foundation's president, said in an email that the "Hearts for Fashion Show" is being hosted by the American Heart Association and Boston Scientific and will take place from 11 a.m. to 1 p.m. Feb. 7, with the survivor component from 10-11 a.m.

January 5th

The Role of Screening for Sudden Cardiac Death in Young Competitive Athletes: A Critical Review

Sudden cardiac death (SCD) is the leading medical cause of death in athletes. In a new article published in Current Physical Medicine and Rehabilitation Reports, Irfan Asif, MD, of the Greenville TN Health System and Kimberly Harmon, MD, of the University of Washington, present a review of the literature on screening for sudden cardiac death in young competitive athletes.

January 4th

Mason-led Research Team Unveils Unprecedented Study on Sports Physicals for Young Athletes

Shane CaswellFAIRFAX, VA--A team led by George Mason University researchers says not enough is being done uniformly across the United States to ensure the safety of children when it comes to detecting cardiac and other health conditions through sports physicals.

January 1st

Why Do Only Some People with Hereditary Heart Disease Experience Symptoms?

MAYWOOD, IL--As many as 500,000 people in the United States have a heritable and potentially fatal heart disease called hypertrophic cardiomyopathy (HCM).

The disease can cause irregular heartbeats, heart valve problems, heart failure and, in rare cases, sudden cardiac death in young people. But some people who carry gene mutations that cause hypertrophic cardiomyopathy never experience symptoms.

A new study helps explain why. For the first time, researchers have found that, in addition to gene mutations, environmental stress plays a key role in development of the disease.

The study, led by senior author Sakthivel Sadayappan, PhD, MBA, of Loyola University Chicago Stritch School of Medicine, is published in the Journal of Molecular and Cellular Cardiology.

Mission & Vision

The mission of the Sudden Cardiac Arrest (SCA) Foundation is to prevent death and disability from sudden cardiac arrest. The vision of the SCA Foundation is to increase awareness about sudden cardiac arrest and influence attitudinal and behavioral changes that will reduce mortality and morbidity from SCA.

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