Improving healthcare for all

Archeon Medical obtains FDA authorization for its pulmonary ventilation solution

The commercialization of EOlife _the AI-based system developed by Archeon_, has just been approved by the US authority, two years after it was commercialized in Europe.

28 Jun 2023

Cardiac arrest is still the world’s leading cause of death. The 30-day survival rate after an out-of-hospital cardiac arrest is between 4% and 5%.

With 400,000 deaths from heart attacks a year, the USA represents 40% of the global market. EOlife would thus save the lives of at least 25,000 Americans a year, and almost $20,000 per patient.

EOlife is the first smart system that helps manual pulmonary ventilation for patients in cardiopulmonary arrest. This system supports and guides first aid measures during this type of incident. 

The tool measures the quality of ventilation via a sensor fitted to the oxygen mask. It calculates the quantities of oxygen given to patient and the return exhalation. The device has software installed that interprets these measurements and determines the victim’s lung profile in order to adjust the amount of oxygen needed, in real time.

“EOlife could save 25,000 lives a year in the USA. Studies have demonstrated that correctly implemented ventilation doubles the chances of survival. This device removes a burden from the minds of medical professionals, given that they are required to carry out work without access to the victim’s medical records and in an extremely stressful environment. (…) Today, only EOlife indicates whether the patient is well oxygenated,” Alban de Luca, CEO and co-founder of Archeon Medical.

The FDA issued this essential authorization at the beginning of April, after a lengthy two-year homologation process, which is different from the European process. Archeon had to provide data collected from US users. Its solution has therefore been tested by around thirty emergency medical teams. “They submitted reports and letters of support to the FDA, highlighting all the device’s benefits in the treatment of patients in life-threatening emergencies, and have thus removed any doubts about the ease and risks of use,”said Alban De Luca, CEO and founder of the company.

The device developed by Archeon Medical improves the quality and safety of the ventilation in all patients requiring manual ventilation. With adequate training, this device may be quickly and easily used in pre-hospital and hospital environments,” Dr. Joseph Finney and Dr. Fahd Ahmad, Director of Emergency Medical Services and Director of Research at Washington University Saint Louis respectively.

In order to obtain this authorization, the Archeon teams were required to adapt the product to US standards. The software, vocabulary, interface, units of measurement and protocols have been modified, based in particular on the recommendations of the American Heart Association.

After the USA, Archeon is continuing its development on the North American continent. EOlife X is currently being distributed in the Canadian province of Saskatchewan by teams from Stat Medical.

Archeon, an artificial intelligence pioneer in the field of pulmonary ventilation, was established in France in January 2018. In February 2022, the startup raised €5.5 million to pursue the development of new ventilation technologies in over 15 countries across Europe, the Middle East, Asia-Pacific and North America.

200 departments and emergency and training centers now use EOlife.

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