QuantalX wins FDA De Novo for a TMS-EEG test of brain function
The Delphi-MD system stimulates the brain with magnetic pulses and records the response with EEG to benchmark brain health.
QuantalX has received FDA De Novo authorization for its Delphi-MD system, creating a new category of device for assessing brain function. It combines TMS, which gives the brain a brief magnetic “ping”, with EEG to measure how key brain networks respond, and compares the result with age-based norms. The company says the device also holds Breakthrough designations for detecting stroke, dementia and normal pressure hydrocephalus.
Measuring the brain’s response to stimulation, not just its resting activity, could offer objective markers for neurological conditions.