Volta Medical obtains CE marking to market its AI tool dedicated to cardiac pathologies

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It was a prerequisite for its dissemination in European cardiology centers: Volta Medical announces that it has obtained CE marking for its artificial intelligence software in interventional rhythmology. This commercial launch should take place in mid-2020 with the aim of reaching around twenty equipped centers within two years. It will be accompanied by training of surgeons by certified doctors (who have already treated at least ten patients).

Detect atrial fibrillation earlier

Atrial fibrillation (AF) is considered to be the most complex and widespread arrhythmia in the world with 33.5 million people affected, including 11 million in the European Union. It is characterized by anarchic, rapid and irregular contractions that prevent the heart from pumping blood properly. Volta Medical’s software compiles, analyzes, processes, and outputs a wealth of data that helps the doctor more easily and accurately detect these intracardiac electrical signals that cause fibrillation, and guides them during surgery to treat the condition.

 "Our cutting-edge medical innovation facilitates the procedure and efficiency of the cardiac surgeon, thereby improving the results obtained and the quality of life for patients" highlight the 4 co-founders, the doctors Julien Seitz, Clément Bars and Jérôme Kalifa (based in United States), experts in interventional rhythmology, and engineer Théophile Mohr Durdez.

Institute a new standard of care

BPIfrance is providing 1.5 million euros to support part of a program comprising several clinical studies with more than 450 patients worldwide. The latter will also study the feasibility of new artificial intelligence projects in cardiology in the operating room. To design and develop its automated referral tool for the treatment of atrial fibrillation, Volta Medical relied on electrophysiologists and scientists. The company, which today has around twenty multidisciplinary employees, claims that this module has been validated in 115 patients with very promising preliminary clinical follow-up. Its goal is to eventually establish it as a standard of care.

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