Neola Medical has reached several critical milestones aligned with its business strategy, aimed at market approval by the FDA. A Human Factors Validation Study of the company’s medical device for lung monitoring, Neola®, was successfully concluded with neonatal nurses in the USA, and will lay a foundation for the upcoming market grant application to FDA. Additionally, Neola® obtained a CB certificate according to high International standards, meeting partial regulatory requirements for market approval in the USA.
“These achievements lay a strong foundation for our upcoming FDA application for market approval in the USA. We now advance to the clinical validation phase and intensify planning for the clinical study in the USA on preterm born infants.”, says CEO Hanna Sjöström.
Read more about the latest news in the investor letter summer 2024, attached to this press release and available on the company’s website www.neolamedical.se