BioDirection, a privately held medical device company developing novel and rapid point-of-care products for the objective detection of concussion and other traumatic brain injury (TBI), today announced that it recently filed a Pre-Submission (“Pre-Sub”) Package with the FDA as a critical step toward commercialization of its proprietary Tbit™ diagnostic platform. BioDirection’s Pre-Sub meeting with FDA Read more about A truly disruptive diagnostic platform which has the potential to revolutionize the detection, diagnosis and management of a concussion[…]