Monebo Technologies Obtains FDA Clearance to Market Intelligent ECG Algorithm
Austin, TX, May 2, 2005: Monebo Technologies, Inc. today announced that its Intelligent ECG Algorithm is now available, following clearance by the United States Food and Drug Administration (FDA). This is a major milestone for the company and represents the culmination of over three years of intense research and development. The Intelligent Algorithm offers a unique solution to the detection of arrhythmias of the heart by interpreting a patient’s electrocardiogram (ECG) on a beat-by-beat basis. The technology will be licensed to medical device companies worldwide for incorporation into products that monitor cardiac electrical activity.
The algorithm is unique because it provides beat-by-beat detection and classification of cardiac electrical signals utilizing a platform that employs adaptive filtering. In this approach, the program recognizes patterns of data, similar to the logic a physician applies when interpreting diagnostic tests. This allows for precise assessment of heart electrical activity and also makes the computer code extremely compact and efficient. The combination of these benefits creates an attractive option for patient monitoring, especially in an ambulatory setting.
“We are extremely pleased with this significant milestone,” stated Dale Misczynski, President and CEO. “Our first FDA clearance will allow us to offer clinicians and patients a new tool for monitoring ECGs, and can be used in a variety of devices. ECG monitoring is critical in the management of cardiac disease, and we believe the Monebo system represents a true advancement. The ECG market is moving more toward ambulatory monitoring and our algorithm is particularly well suited for this application.”
“This is the first in a suite of products aimed at enhancing patient outcomes while improving patient convenience,” continued Misczynski. “Our innovative approach will allow us to push the boundaries of ECG technology and, together with clinicians, explore new solutions to cardiac disease and disease management” .
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