As the year draws to a close, we are proud to highlight one of our key milestones of 2024—the successful completion of the Human Factors Validation Study for our lung monitoring device, Neola®. The study was conducted in Boston, USA, to validate the usability of the medical device Neola®, and demonstrate that it is safe for its intended use by healthcare professionals in neonatal intensive care units. The successful results from the study are of great significance, as they will be included in our forthcoming FDA application for market approval in the U.S.—an important step toward the market launch of Neola®.
In this video interview, Magnus Johnsson, Director QA & RA at Neola Medical, shares more about the Human Factors Validation Study and its significance for our journey toward FDA approval. Watch it here (in Swedish):