Business
Monivent: Monivent has signed an agreement with Stanford for usability study in the US
Monivent: Monivent has signed an agreement with Stanford for usability study in the
About this update from Monivent Ab
Press release from Companies Publicerat: 2024-09-27 08:00:00 Monivent AB: Monivent has signed an agreement with Stanford for usability study in the US Monivent AB announces that the company has signed an agreement with Stanford on behalf of the simulation center CAPE, Center for Advanced Pediatric and Perinatal Education, for the implementation of the planned usability study in the US. The usability study, which is a necessary part of the application for market approval in the US, will be conducted in October to enable finalizing the 510(k) submission to the FDA shortly after that. Conducting a usability study, analyzing how US healthcare professionals interact with the Neo100 system during use in a simulated setting, is what remains before Monivent can complete and submit its application to the FDA regarding market approval for Neo100 in the US. Monivent can now announce that an agreement has been signed for the implementation of this usability study together with CAPE. CAPE is a unique simulation center for training and research in neonatology and pediatrics with the aim of leading innovation and dissemination of new methods to improve human machine interaction and performance in the delivery of healthcare. CAPE is located at Packard Children's Hospital Stanford, which provides access to several clinical disciplines for participation in usability studies. CAPE was founded and is led by Dr. Louis P. Halamek, who is a professor in the Division of Neonatal and Developmental Medicine at Stanford University and holds a clinical position at Lucile Packard Children's Hospital at Stanford. Dr. Halamek is also Associate Director of Education and Training in Neonatal-Perinatal Medicine at Stanford University School of Medicine. Through collaboration with NASA, Dr. Halamek has recognized the benefits of a cross-industry approach to risk assessment, safety, and effectiveness, which is applied to the work at CAPE to optimize performance in high-risk activities such as neonatal resuscitation. With this background, the team at CAPE has great knowledge and experience in the care process itself and the unique environment that Neo100 will be used in. They also have the best opportunity to simulate the clinical environment to create a user scenario that is as realistic as possible, which is important for the quality of the study and its results. "The US is a very importan...