News


04.07.2019

evolution duo: compatibility with Philips Azurion confirmed

13.06.2019

MDSAP certificate for electrophysiology system

The medical-technology company fulfils another requirement for international success

Schwarzer Cardiotek’s electrophysiology system EP-TRACER is used in cath labs worldwide. Catalyzed by the distribution agreement with Medtronic, success in international sales projects continues. The MDSAP certificate, which CardioTek B.V. received yesterday, further strengthens the international business.

Within the MDSAP, Medical Device Single Audit Program, different regulatory authorities cooperate internationally to examine all regulatory requirements within one audit. For manufacturers like Schwarzer Cardiotek, the certificate simplifies market entry within the participating countries.

The MDSAP certificate supports the registration of EP-TRACER 2 in Brazil. Also, for distribution in the USA, the certificate is helpful in addition to the FDA clearance. The company received the FDA clearance for the recent software version 2.2 at the beginning of the year.
08.05.2019

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

07.11.2018

Medtronic and Schwarzer Cardiotek announce distribution agreement

30.10.2018

Hemodynamic measurement stations update Munich Municipal Hospitals

27.04.2018

evolution - hemodynamics 2018

12.12.2017

Extended Medtronic EMEA co-marketing cooperation

06.12.2017

Toshiba Medical Systems - European distribution agreement

28.04.2017

Schwarzer Cardiotek introduces software version 2.2 for the electrophysiological measuring system EP-TRACER.

19.08.2016

Schwarzer Cardiotek receives FDA 510(k) clearance for software version 2

09.08.2016

EP-TRACER - The Film

09.08.2016

New User Reports about EP-TRACER Portable

17.12.2015

Schwarzer Cardiotek presents software version 2 of its electrophysiogical measuring system EP-TRACER

31.07.2015

Schwarzer Cardiotek concludes filling of key management-level positions

02.04.2015

Philips und Schwarzer Cardiotek conclude reseller agreement for the cardiology information system cardWorks

18.06.2014

Schwarzer GmbH, Heilbronn Germany, And Cardiotek B.V., Maastricht, The Netherlands Announces That The Two Companies Will Merge Under The New Brand Of Schwarzer Cardiotek

07.05.2014

Cardiotek Announces U.S. Commercialization of the EP-Tracer System Company to Showcase the System at 2014 HRS Meeting