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Schwarzer Cardiotek receives FDA 510(k) clearance for software version 2.2

Heilbronn, May 8th, 2019 - Schwarzer Cardiotek today announced that it was granted 510(k) clearance by the United States Food and Drug Administration for the software version 2.2 of its electrophysiological 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.

New Features of software version 2.2 include the display of the compound motor action potential (CMAP) and venous pressure response during pacing of the phrenic nerve, a method typically applied during ablation procedures of atrial fibrillation.

Other new features include immediate screenshots and export of relevant images to the final report, which can be automatically generated according to user-specific templates and – if desired – may be stored on the hospital network.

“The EP-TRACER’s ability to display the cryo-curve in real-time, together with the visualization of the response of phrenic nerve pacing greatly improves comfort and safety during my cryo-ablation procedures”, says Prof. Dr. Carlo de Asmundis at Universitair Ziekenhuis Brussel, Belgium.

Frank-Peter Klein, President & CEO of Schwarzer Cardiotek comments “Atrial fibrillation is becoming an epidemic burden in our society. Giving electrophysiologists the opportunity to treat it most efficiently at the lowest possible risk is a motivation which has led to the improvements of EP-TRACER and its new software release.”

EP‐TRACER is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The world’s most compact, easy-to-use recording system provides superior signal clarity with a built-in dual channel programmable stimulator for electrophysiology (EP) studies. The system is commercially available in Europe, Central and South America, Asia Pacific, Africa and the Middle East.

About Schwarzer Cardiotek
Schwarzer Cardiotek is a private medical technology company focusing 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 manufacturing 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 evolve its products and stay on the cutting edge of technological innovation. For more information, see

Press Contact
Schwarzer Cardiotek GmbH
Sabine Voith
Phone +49 (0)7131 2774 500

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