Medicalgorithmics begins certification of VCAST technology on the EU market

Medicalgorithmics has achieved another milestone and is starting the CE certification process for VCAST technology, used for non-invasive diagnosis of the condition of coronary arteries, the company announced. VCAST technology based on artificial intelligence is developed by Kardiolytics Inc. – a subsidiary of Medicalgorithmics.

“Medicalgorithmics has achieved an important milestone in the development of VCAST technology, as defined in the announcement in June this year. new development strategy of the company. October 3 this year – by signing an agreement with the TÜV Rheinland Polska certification body – medtech has started a formal process of assessing the compliance of the technology with EU requirements for medical services,” we read in the release.

Successful completion of the process of assessing the compliance of VCAST technology with European requirements will result in the issuance of a CE certificate, which is necessary for the commercial introduction of VCAST to the European Union market, it was explained.

“The start of the certification process is a very important milestone that brings us closer to the commercialization of VCAST technology in the European Union. After obtaining the CE certificate confirming VCAST’s compliance with EU requirements for medical technologies, we will register the system with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, which will enable us to offer VCAST technology in Poland. Additionally, after obtaining CE, we will submit applications to regulators in other EU countries and in Australia, Great Britain and Switzerland, which we consider to be key in terms of sales potential. Thanks to this, in 2024 VCAST will be fully available to partners from these countries,” said Przemysław Tadla, member of the Management Board of Medicalgorithmics for technology and COO at Kardiolytics, quoted in the release.

In September this year Medicalgorithmics signed a letter of intent with Grupa Diagnostyka regarding the use of VCAST technology for the diagnosis of coronary heart disease in the partner’s diagnostic facilities.

Virtual Cardiac Stress Test (VCAST) is a medical system patented and developed by Kardiolytics – a subsidiary of Medicalgorithmics – used for non-invasive analysis of the condition of coronary vessels for the diagnosis of coronary heart disease. The diagnosis is made based on cardiac computed tomography data, which are analyzed by a set of artificial intelligence algorithms developed by Kardiolytics. Thanks to it, doctors receive quick information about the condition of the patient’s coronary arteries, without the need to resort to the risky, invasive and expensive coronary angiography procedure each time, it was explained.

“The growing global number of coronary heart disease cases and the aging patient population in highly developed countries are factors that make us see enormous market potential for VCAST technology. In the USA alone, it may be used in the diagnosis and treatment of over 10 million cardiac patients. Therefore, I am very glad that after the development stage, Medicalgorithmics and Kardiolytics have taken the first step towards commercialization of the VCAST system. The technology of personalized, three-dimensional modeling of coronary arteries using a proprietary artificial intelligence system is to become another business leg for Medicalgorithmics, next to the diagnosis of cardiac arrhythmias,” said Kris Siemionow, member of the supervisory board of Medicalgorithmics and managing partner of Biofund Capital Management LLC – the main shareholder of the company.

Kardiolytics – a company that creates solutions for medicine based on artificial intelligence – joined the Medicalgorithmics capital group in November 2022. This was part of Biofund Capital Management LLC’s investment in cardiology medtech.

In accordance with the announcement in June this year. development strategy, Medicalgorithmics plans to submit an application to the US Food and Drug Administration (FDA) in the first half of 2024 for admission of the VCAST technology to the US market, the information summarizes.

Medicalgorithmics is a high-technology company operating in the field of non-invasive medical devices, present on the market since 2005. The company operates, among others, in the USA and Asia. In 2014, the company moved to the main market of the Warsaw Stock Exchange from NewConnect, where it had been listed since 2011. It is included in the sWIG80 index.

Source

Our privacy policy