Schwarzer Cardiotek receives FDA 510(k) clearance for software version 2
HEILBRONN, August 19th, 2016 - Schwarzer Cardiotek today announced that was granted 510(k) clearance by the United States Food and Drug Administration for the software version 2 of its electrophysiogical measuring system EP-TRACER. The EP-TRACER is an electrophysiological measurement system, which was developed to display intracardiac ECG signals at the highest possible signal quality.
The new features delivered by the software include simplified operability with refined representations of the signal types, improved analysis and reporting functions, as well as the connectivity to cryo-consoles.
The EP-TRACER has acquired an excellent reputation in professional circles in Europe and has been praised by key opinion leaders for the improvements of the new software.
"We use EP-TRACER 2 as a recording, stimulation and measurement system in our EP department because of its excellent speed, high quality of intracardiac signals and ease of use. It enables us to quickly get to precise and reliable results." states Dr. Tom de Potter, Associate Director of the Cardiovascular Center at OLV Aalst, Belgium. "We feel that the new software is a real improvement and most beneficial to our studies.“
Attractive US market
Electrophysiology is a $3 billion global market that is growing at nearly 10% annually. In particular, the US market offers high revenue opportunities simply because of its immense size.
“The clearance is of high strategic value for the company as it is the ticket to enter the biggest EP market worldwide”, explains Frank-Peter Klein, President and Chief Comercial Officer for Schwarzer Cardiotek.
Schwarzer Cardiotek`s EP-TRACER and the software version 2 will be on display at booth # E4-O300 at the ESC in Rome from 27th to 30th August 2016.
About Schwarzer Cardiotek
Schwarzer Cardiotek is a private medical technology company with a focus on electrophysiological and hemodynamic measurement systems and cardiology information systems. The company can look back on a 60-year-old tradition in the development and manufacture of polygraphical recording systems. Schwarzer Cardiotek relies on the overarching approach of creative thinking and collaboration with leading physicians and researchers from across the globe, to continually develop its products and stay at the cutting edge of technological innovation. For more information, see www.schwarzercardiotek.com.
About the EP-TRACER
The EP‐TRACER system is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The compact, easy-to-use recording system now offers, in addition to the excellent signal quality and an integrated programmable stimulator for electrophysiological studies. The EP-TRACER system as well as the software version “EP-TRACER 2” is CE-tested and FDA 510(k) approved. It is sold in Europe, Central and South America, the USA, Asia Pacific and the Middle East markets. There are about 1,000 systems in use worldwide.
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