Press communication
Lund, Sweden, February 29
This is a translation of the Swedish press release published 2024-02-29, 07.00 CET
Neola Medical AB (publ) will commence a Human Factors Validation Study in March 2024 with Neola®, the company’s medical device for continuous lung monitoring of preterm born infants. The study will take place in Boston, USA, aiming to validate the usability of the medical device, Neola®. Usability evaluation is a regulatory requirement by the FDA, and the study report will be submitted as part of Neola Medical’s application to the FDA for market approval ahead of the product launch in the USA.
The study is led by Custom Medical, global experts in usability studies, and will be conducted at a usability testing center in Boston during March 2024. The study design has been approved by the FDA during a pre-submission meeting, and the initial work has commenced as planned. The participants in the study consist of 15 neonatal nurses from various neonatal intensive care units in the USA, with varying levels of experience in the field. Neola Medical’s own employees will be present in Boston to train the study participants in the use of Neola®. The goal of the study is to assess how well the participants interact with Neola® and demonstrate its safety for its intended use by healthcare professionals in neonatal intensive care units. After the completion of the study, the collected data will be evaluated, and the findings will form the basis for the upcoming FDA application for market approval of Neola® in the USA.
“It is gratifying that we can now commence the Human Factors Validation Study for FDA approval, which is a crucial step towards the market launch of Neola®. Our goal is to gather valuable data regarding the usability of Neola® and assess how well our medical device integrates into neonatal intensive care and can be utilized by neonatal nurses.”, says CEO Hanna Sjöström.
For further information, contact:
Hanna Sjöström, CEO Neola Medical, phone: +46 (0)760-10 71 16, e-mail: hanna.sjostrom@neolamedical.com
Neola Medical AB (publ) develops medical technology device for continuous monitoring of preterm born infants’ lungs. Immediate detection of complications provides the possibility of early treatment and improved health care. The patented technology is based on a spectroscopic method developed at Lund University in Sweden. The company was founded in 2016 and is listed on NASDAQ First North Growth Market (ticker: NEOLA). Read more at www.neolamedical.com. The company’s Certified Adviser is FNCA Sweden AB.