QuantalX gains de novo classification for neuro-imaging system

QuantalX’s Delphi-MD is applicable for the diagnosis, monitoring, and treatment evaluation of a range of neurological conditions.

QuantalX Neuroscience’s Delphi-MD, a device to monitor and evaluate brain health, has gained de novo classification from the US Food and Drug Administration (FDA), green-lighting the company to commercialise the device at imaging centres across the US.

Delphi-MD is comprised of an electroencephalography (EEG) sensor array ‘cap’ worn on a patient’s head and a processing console. Following the delivery of transcranial magnetic stimulation (TMS) pulses, the EEG sensor captures the brain’s real time response to TMS and creates an image of the brain’s network.

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