Piloting MEDEI’s SMART-TRIAL data management platform to better document the efficacy and safety of its brain network activation technology
One of the world’s leading neurotechnology innovation companies, ElMindA of Herzliya, Israel, today announces that it aims to further improve documentation of its brain healthcare research and development programs through the applied use of software from MEDEI ApS. ElMindA will now pilot MEDEI’s SMART-TRIAL data management platform in two projects in the United States to 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. We believe that the SMART-TRIAL data management platform will help us to achieve these mandatory goals.”
Said Liran Korine, ElMindA’s Director of Clinical Affairs.
“MEDEI is changing the way that medical device manufacturers can better manage their data in the development and roll-out of their products,” adds Páll 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 to 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 seminar together with MedicSense and the Embassy of Denmark, Israel for professionals in the medical device industry on 10th April 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 now
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.
For further information and images, please contact:
Jón Ingi Bergsteinsson
Vice President for Global Business Development
Tel: +45 42 70 70 03