Client Need
Epiminder is an Australian medical device company. Their focus is developing an implantable device for continuous and remote monitoring of brain activity in persons with epilepsy. They engaged MCRA for multiple services and leadership to develop their FDA Breakthrough Designation.
MCRA helped Epiminder receive an FDA Breakthrough Designation for their device, Minder.
MCRA Approach
MCRA’s Neurology Team, led by John Doucet, assisted Epiminder with developing the strategy for the Breakthrough Designation request and writing the Breakthrough Designation request. Dr. Doucet also played a key role in developing responses to FDA’s request for additional information during the review.
MCRA THERAPY: Neurology
MCRA SERVICES: US Regulatory, Biocompatibility, and Clinical Data Analysis
Outcome
MCRA was a key player on the Epiminder Team responsible for obtaining this crucial FDA Breakthrough Device designation. MCRA’s Neurology Team and Dr. Doucet are continuing to lead the ongoing efforts to work with the FDA and obtain marketing authorization for the Epiminder device.
