ProductLife Group as a strategic partner of an EIT Health consortium supporting an innovative project, APNEAL project

ProductLife Group is a French global consultancy providing regulatory, pharmacovigilance, CMC & Quality support in 150 countries across 5 continents; it is a member of EIT Health, part of the network of key partners and has been a strategic partner of the startup Apneal in its innovative project.

APNEAL, a French startup that seeks to improve and help in the diagnosis of sleep apnea, was selected by EIT Health Flagships: a program endowed with more than 2 million euros that will accelerate the development of its mobile application for the detection and diagnosis of sleep apnea.

Apneal introduces revolutionary advances in sleep apnea testing with the world's first technology for advanced at-home testing with diagnostic accuracy, using only the patient's smartphone attached to the chest with an adhesive bandage. Leveraging basic smartphone sensors, APNEAL records the patient's breathing movements and sounds during sleep. These data are transformed by sophisticated artificial intelligence algorithms into signals equivalent to those obtained by advanced clinical examinations (e.g. ventilatory polygraphy), allowing the automatic detection of cardiac and respiratory events. Once the recording is complete, the technology generates an examination report with access to metrics to assess sleep quality. The results are then communicated to the physician on an ergonomic dashboard prior to patient management.

Thanks to the EIT Health Flagships programme, APNEAL gets financial backing and operational support through a network of key players in the European sleep apnoea ecosystem.

What is PLG's role in the APNEAL project and why did we do it?

ProductLife Group is instrumental as a regulatory partner within this consortium, providing expert guidance on regulatory compliance and audit preparation. PLG's participation in the consortium deepens our regulatory expertise and helps accelerate patient access to innovative health technologies. By bridging the gap between cutting-edge research and regulatory approval, PLG is poised to revolutionize the home sleep testing landscape, ultimately improving patient access to innovative health technologies.