The clinical validation study for our MSCopilot mobile medical application is launched!
« MSCopilot is our CE-marked software medical device dedicated to Multiple Sclerosis assessment. With this multicentric validation study, we are taking an exciting new step forward and we look forward to entrusting this technology to patients » announces Saad Zinaï, MD, Ad Scientiam’s Chief Medical Officer.
MSCopilot has been developed by Ad Scientiam for the past 2.5 years, with a board of 12 neurologists specialized in MS, leading patient advocacy groups in France and the institutional support of Roche France. Having just obtained its CE-marking as a class I medical device, the application will start distribution end of November in France, on iOS and Android store. http://www.mscopilot.com
To complete its CE marking, certifying MSCopilot compliance with European regulatory requirements, Ad Scientiam is preparing its 510(k) pre-market submission to the FDA.
In parallel, Ad Scientiam is the sponsor of a multi-centric clinical validation study on MSCopilot.
This clinical study gathers teams from 10 French hospitals specialized in MS, with first participants already recruited.
The objective is to correlate scores coming from MSCopilot with the scores from the MSFC (Multiple Sclerosis Functional Composite) scale, the international Gold Standard on MS, and to demonstrate the reliability of MSCopilot results in clinical practice.
« This correlation was demonstrated in 2016 through a first pilot study. Now, we have the opportunity to validate the relevance of MSCopilot for the monitoring of patients with MS on a large scale » explains Dr. Elisabeth MAILLART, MD, neurologist at the Pitié-Salpêtrière hospital and principal investigator of the MSCopilot study.
With an ambitious recruitment goal of over 200 patients and healthy volunteers, Ad Scientiam mobilizes its medical and clinical teams to support the hospitals in recruiting the first participants and delivering the application.