Startup developing ECG devices receives important certification
30. 09. 2024
The 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 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 optimal therapy. A significant advantage is the ease of use and interpretation of the results.
The system, which 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 Scientific Instruments 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 developing the technology. The applications are very broad and cover the entire field of cardiac electrophysiology.
Photo from the VDI Technologies exhibition in Berlin at the EHRA 2024 conference.
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.
More information on VDI Technologies can be found here.
ISO certificate obtained by the VDI Technologies company.
Source: Institute of Scientific Instruments of the CAS
Photo: Institute of Scientific Instruments of the CAS; Shutterstock
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The Czech Academy of Sciences (the CAS)
The mission of the CAS
The primary mission of the CAS is to conduct research in a broad spectrum of natural, technical and social sciences as well as humanities. This research aims to advance progress of scientific knowledge at the international level, considering, however, the specific needs of the Czech society and the national culture.
President of the CAS
Prof. Eva Zažímalová has started her second term of office in May 2021. She is a respected scientist, and a Professor of Plant Anatomy and Physiology.
She is also a part of GCSA of the EU.