FDA approves Medtronic's GEM III ICD (implantable cardioverter defibrillator):
This article was originally published in Clinica
Executive Summary
The US FDA has approved for sale Medtronic's GEM III AT implantable cardioverter defibrillator (ICD) for managing patients with ventricular tachyarrhythmia with or without atrial fibrillation. The Minneapolis, Minnesota company said the device offers a number of enhancements compared to its GEM II and Jewel AF ICDs. It includes the InCheck AT Patient Assistant, which provides: ambulatory symptom marking and heart rhythm status to the patient; an improved version of its PR Logic dual chamber detection algorithm, which increases its ability to distinguish between lethal and nonlethal arrhythmias; and increased energy output.
You may also be interested in...
Investors Go Berserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.