Is WAVi FDA cleared, and what does the clearance cover?
Yes. WAVi is an FDA 510(k) cleared EEG and event-related-potential assessment system (K213900). The clearance covers acquisition, display, and storage of EEG and ERP data to aid in diagnosis. It is not a clearance to detect or diagnose any specific condition, and it is not a standalone diagnostic test. The clinician interprets the data and makes the clinical decision.
How is it coded, and is it covered?
Coverage is decided by your payer on the documented indication. WAVi is billed under the standard codes for the services performed, and the cognitive assessment visit is billed separately when it is performed and documented. Read your Medicare contractor's policy in the CMS Medicare Coverage Database and confirm every code with your certified coder before the first claim.
How long does a scan take, and who reads it?
About twenty minutes with the headset on, run by a trained tech rather than the physician. Placement uses gel-free saline sensors in a routine clinical setting, with no gel and no prep beyond seating the patient. A board-certified neurologist interprets the data and signs the report through BMTG. Credentials are on file, available on request. Ask your TITN contact, or email support@transitionitnow.com, for the credentials packet: board certification and licensure.
What is the difference between qEEG and a routine clinical EEG?
A routine clinical EEG is read visually for standard patterns, such as epileptiform activity, by an interpreting physician. Quantitative EEG digitizes the same recorded signal and compares features like band power statistically against a normative database. qEEG does not replace a diagnostic EEG ordered to rule out epilepsy; it adds quantified numbers that a baseline and a retest can be compared on.
What do P300 amplitude and latency actually measure?
P300 is an event-related potential recorded during an auditory oddball task, reflecting attention allocation and the speed of stimulus evaluation. WAVi records its amplitude and latency alongside reaction time. Reduced amplitude and prolonged latency are associated with cognitive slowing in several conditions, but these markers are not specific to any single disease and are interpreted by the clinician in context.
Can WAVi track change over time?
Yes. Every scan is quantified on the same protocol, so a baseline and a retest compare directly against each other rather than only against a population norm. That is the usual reason practices keep it: one scan is a snapshot, two on the same protocol are a trend. Retest frequency is decided by your payer on documented medical necessity.
How does baseline-and-retest testing work for concussion tracking?
A baseline is captured before injury or early in care, then the same protocol is repeated after a suspected event and compared against that patient's own baseline. WAVi documents the measured change. Your clinical team makes the return-to-play call; published guidance is clear that tools like this should not be used alone for diagnosis or return-to-play decisions.
Is a WAVi assessment the same as a full neuropsychological evaluation?
No. A WAVi scan is a brief, quantified EEG and ERP assessment; a neuropsychological evaluation is a comprehensive battery administered and interpreted by a neuropsychologist. They answer different questions. WAVi is a complementary data point next to the exam and the history, not a substitute where full neuropsychological testing is clinically indicated.
Are there reasons a patient should not have a WAVi scan?
Standard EEG-type limitations apply. Scalp wounds, lesions, or skin conditions at electrode sites can prevent good contact, and a patient who cannot sit reasonably still for the recording will not produce usable data. Eligibility is a clinical judgment for the ordering provider, made per the device documentation, not a blanket assumption that every patient can be scanned.
Can a WAVi report support a medical-legal case?
Downstream, yes. When a provider orders WAVi and shares the report with counsel, BMTG can produce a Post-Injury Brain Function Report with quantified neurodiagnostic documentation signed by a board-certified neurologist. Admissibility is decided by the court and varies by jurisdiction; some courts have excluded quantitative EEG evidence offered as proof of brain injury, so treat it as documentation, not as settled proof.
Pairs with · Body
Pairs with · Molecular
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