Epsidy, the start-up specializing in women’s cardiovascular health, receives ISO 13485 certification

The young start-up, which has been awarded the Deeptech label by BPI, has just obtained its ISO 13485 certification, with a view to continuing its strong development, and marketing highly innovative medical devices for cardiac imaging. This certification guarantees that the company’s services meet the highest quality and safety standards.

Several players in the fields of research and electrical engineering have collaborated to create : Myline Cottance, PhD in electrical engineering, Guillaume Calmon, civil engineer, Jacques Felblinger, , and Freddy Odille.聽 These passionate experts pooled their knowledge and created Epsidy with the dual aim of revolutionizing clinical knowledge of cardiovascular diseases and electrical signals, and improving cardiac imaging and medical care for all.

Women, the forgotten victims of heart risk prevention

Above all, the aim is to improve care for women, who, contrary to popular belief, are more affected by cardiovascular disease than men. They are at greater risk of heart disease at an earlier age, and are slow to be detected, partly due to a lack of awareness of the specific symptoms that women suffer from. As a result, they are treated later and have a lower survival rate than their male counterparts.

Epsidy’s teams of electrical engineers are currently revolutionizing this treatment. In particular, they have developed a cardiac MRI solution based on Artificial Intelligence, which captures over 95% of heartbeats, thanks to the synchronization of cardiac images obtained by MRI with heartbeats detected by electrocardiogram. This is a much higher rate than is possible with conventional techniques, which rely on only one of these two methods. Several French institutions are already experimenting with this solution, as is University College London.

Export projects to establish a leadership position in intelligent imaging

The Lorraine-based Medtech start-up, which was founded two years ago, is already very successful on the export front, and plans to roll out several commercial projects in Germany, the UK and the USA. In this context, the next stage of development identified is to obtain CE marking, followed by FDA approval, a process which should be greatly facilitated by the award of this ISO 13485 certification. In the near future, the company also intends to offer an innovative electrocardiogram (ECG) vest, accurate and adapted to both male and female morphologies, to better detect certain pathologies.

In order to achieve these objectives, Epsidy is aiming to raise 鈧450,000 to finance part of its development and R&D activities. It estimates its total needs at 鈧1.7 million, an amount that could potentially enable the young company to establish a definite leadership position in the world of intelligent cardiac imaging, and launch a major revolution in favor of women’s health.

Certification Iso d'Epsidy
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