Startup developing ECG devices receives important certification

Academic startup VDI Technologies has reached a significant milestone, achieving ISO 13485 certification for activities that include developing, manufacturing, and selling medical devices for electrocardiography. The rigorous certification is a prerequisite for commercializing the new ultra-high frequency ECG (VDI UHF-ECG) technology.

This technology, originating from the Institute of Scientific Instruments of the CAS, enables accurate, non-invasive diagnosis of electrical activation of the heart ventricles by processing extremely weak ultra-high frequency ECG signals. The VDI UHF-ECG thus allows the targeting of the disturbances in the electrical activation of the heart and the selection of the optimal therapy. A significant advantage is the ease of use and interpretation of the results.

The technology was wholly designed and implemented in the Czech Republic, is protected by several international patents, and has won international awards. In addition to the Institute of Cardiology of the CAS, the St. Anne's University Hospital in Brno, the University Hospital Královské Vinohrady in Prague, and the Cardion company have also contributed to the technology. The use of the technology is very broad and covers the entire field of cardiac electrophysiology.

The ISO 13485 certificate for VDI Technologies confirms that the startup follows the quality management system requirements and can ensure certified mass production. The VDI UHF-ECG device itself also requires CE MD certification as a medical device. This certification is currently underway.

Contact:
Ing. Pavel Jurák, CSc., Head of Department Medical Signals, ISI CAS: jurak@isibrno.cz

Certificate obtained by spol. VDI Technologies s.r.o.

Photo from the VDI Technologies exhibition in Berlin at the EHRA 2024 conference