The Ahead M-100 is a handheld, non-invasive, non-radiation emitting medical device in development that could provide a rapid and objective assessment and categorization of traumatic brain injury (TBI), based on patterns identified in brain electrical activity.
BrainScope pursued the pre-investigational device exemption (or pre-IDE) process as a mechanism to obtain FDA concurrence on the design elements of an appropriate pivotal clinical trial for its innovative device, even though the Ahead M-100 is a risk device and does not require a formal IDE approved by FDA.
BrainScope president and CEO Michael Singer said it was very important for them to obtain pre-trial input and consensus with FDA, particularly since the technology is unique and innovative and they are looking forward to commencing a pivotal trial in emergency departments across the country.
