News Release
For Immediate Release
Aalborg, Denmark, 20 March 2018
Brain Healthcare Innovator ElMindA Adopting Smart Data
Pilots MEDEI's SMART-TRIAL data management platform tobetter document the efficacy and safety of its brain network activation technology
One of the world's leading neuro technology innovation companies,ElMindAofHerzeliya, Israel, today announces that it aims to further improve documentation of its brain healthcare research and development programs through the applied use of software fromMEDEI ApS. ElMindA will now pilot MEDEI'sSMART-TRIAL data management platform in two projects in the United Statesto document the efficacy and safety of its brain network activation (BNA™) technology and to improve its product research and development programs.
"ElMindA is a data-driven company and constantly aims to improve the quality and visibility of data surrounding our brain healthcare programs and products," saidLiran Korine, ElMindA's Director of Clinical Affairs."We believe that the SMART-TRIAL data management platform will help us to achieve these mandatory goals."
"MEDEI is changing the way that medical device manufacturers can better manage their data in the development and roll-out of their products," addsPáll Jóhannesson, MEDEI's CEO."SMART-TRIAL simplifies the way medical OEMs can document and demonstrate compliance with changing market regulations for clinical safety and effectiveness."
BNA™ is breakthrough technology to monitor and manage the health of a brain throughout the course of anyone's life. It applies sophisticated artificial intelligence based signal processing and analysis algorithms to EEG and clinical data to measure patterns of brain neuronal networks activated during specific brain processes to deliver meaningful insights into brain functionality.
BNA™ is being utilized as a decision support tool for physicians to monitor change in brain neuronal networks function to help identify disease onset and assess treatment efficacy for a broad range of previously elusive conditions such as depression, concussion, or memory loss. The BNA™ Analysis System is used by qualified medical professionals for the post-hoc analysis of the human Electroencephalogram (EEG), utilizing evoked response potentials (ERP). The device is indicated in the U.S. for use in individuals 14 to 24 years of age with the Auditory Oddball evoked potential test.
Seminar in Tel Aviv on recommendations for the new MDR
In separate news from MEDEI, the firm today announces that it will host a seminartogether with MedicSense and the Embassy of Denmark, Israelfor professionals in the medical device industry on 10thApril 2018 in Tel Aviv. With recent updates in regulations and the EU's new Medical Device Recommendation (MDR), more focus is being placed on clinical evaluation. This places a higher strain on both regulatory and clinical operations.
The goal of this seminar is to shed light on the regulatory changes and to share knowledge and experience within the area to better prepare for the upcoming challenges.
Professionals wishing to attend the free seminar can register at https://www.eventbrite.com/e/navigating-the-new-mdr-strategies-for-success-tickets-43017798393
About ElMindA Ltd
ElMindA was founded in 2006 by Professor Amir Geva to address an unmet need to objectively assess brain health and brain-related disorders in order to enhance diagnosis and treatment across a full spectrum of neurological and psychiatric disorders. ElMindA translates state-of-the-art neuroscience via big databases and advanced algorithmic science into clinically meaningful Brain Network Activation (BNA™) maps. ElMindA is a preferred partner of industry-leading organizations based on the rigor of its science and technology development. ElMindA was recognized on Fast Company's 2015 list of the World's Most Innovative Companies, and was named a 2015 World Economic Forum Technology Pioneer.
About MEDEI ApS
MEDEI ApS is a Danish medical software innovator that strives to deliver industry-leading solutions to facilitate the R&D of medical devices. SMART-TRIAL, the firm's flagship platform, is helping medical device manufacturers who want to illustrate the quality and safety of their medical device, by reducing chaos and improving the collection and management of data.Visithttps://www.smart-trial.co
Ends
For further information and images, please contact:
Jón Ingi Bergsteinsson
MEDEI ApS
Vice President for Global Business Development
Tel:+45 42 70 70 03
Email:jib@medei.dk
Hugh Paterson, CEO
Whoosh PR,
Landline:+ 33 (0)9860 77819
Mobile +44 77681 75452
Emailhugh.paterson@whooshpr.com