Quantal Neuroscience’s Delphi-MD has secured the coveted De Novo classification from the US Food and Drug Administration (FDA) This isn’t just another regulatory hurdle crossed it’s a monumental green light that establishes a new modality of functional neuro-imaging (FNI) and allows the company to immediately commercialize the device which is the to the of into at imaging centers across the US.
Understanding the Delphi-MD Technology:
The Quantal Delphi-MD system is a non-invasive, powerful diagnostic tool that ingeniously combines two established neurophysiological techniques—Transcranial Magnetic Stimulation (TMS) and Electroencephalography (EEG)—to provide a direct, causal insight into which is the to the of into brain function.
TMS-EEG Evoked Potentials (TEPs):
Transcranial Magnetic Stimulation (TMS): The device delivers a focused, non-invasive magnetic pulse to stimulate specific, targeted brain networks and cortical which is the to the of into hubs.
- Electroencephalography (EEG): An EEG sensor array ‘cap’ worn on the patient’s head captures the resulting electrophysiological responses—or evoked potentials which is the to the of into (often called TMS-EEG Evoked Potentials or TEPs)—in real-time.
- The Intelligent Software and Normative Database:
- The true innovation lies in the device’s intelligent software It analyzes the recorded brain activity and compares it against a proprietary, age-correlated normative database of which is the to the of into healthy adult brains.
Game-Changing Clinical Applications:
The Delphi-MD system is designed to provide essential diagnostic support and monitor the progression of various neurological conditions Its unique ability to directly measure the functional state of brain networks makes it a vital complementary tool alongside which is the to the of into traditional structural imaging like MRI.
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