Development
BrainScope uses a collaborative network of clinical users, the Company’s Medical Advisory Board and new discoveries by our scientific and research teams to fuel the innovation process. The concept, in conjunction with the medical need and scientific rationale, is extensively evaluated and tested prior to initiation of the product development process – the process by which the concept gets transformed into product specifications, designed, tested and ultimately released into manufacturing. The company complies with [the] ISO 13485 medical device standard and conducts its development, design, and manufacturing processes in accordance with FDA’s Quality System Regulation (QSR) for medical devices, in anticipation of securing FDA marketing clearances and approvals.
In the long term, BrainScope’s future products aim to not only aid the medical professional in assessment of Traumatic Brain Injury, but also to aid assessment of the abnormality and asymmetry of brain function to help distinguish types of stroke, seizure and other functional impairments, and help identify Alzheimer’s/dementia, depression, and other neurologically-based functional impairments. Significant clinical trials will be required to show feasibility and validate clinical utility of these planned adjunctive tools, and separate regulatory agency clearances will likely be necessary for each new indication.