FDA Clears QuantalX’s Delphi-MD, Introducing a Novel Brain Function Monitoring Solution

QuantalX Neuroscience has received FDA De Novo clearance for its Delphi-MD System, marking the introduction of a new clinical technology for brain function evaluation. 

The system is a functional neuro-imaging (FNI) device designed to help clinicians assess brain health, observe neurological disease progression and understand the impact of clinical interventions.

Delphi-MD combines direct transcranial magnetic stimulation (TMS) with electroencephalography (EEG) in a non-invasive procedure. An EEG cap is placed on the patient’s head while radiation-free magnetic stimulation maps functional responses across key brain network areas. 

Intelligent software then compares the results against a proprietary, age-matched normative database of healthy brain responses. A full scan and report can be completed in under an hour.

The technology is designed to provide practical, clinically usable insight into brain activity, adding information that traditional structural imaging does not capture. The system requires no dedicated infrastructure and offers a cost-effective solution for hospitals and clinics.

Delphi-MD has already been used in research settings, including at major US academic centres, to support studies in areas such as brain injury and neurological disorders. 

With FDA and European CE-MDR approvals in place, commercial deployment is now expanding across medical facilities in the United States and Europe.