Our Brain in Action

By Dr. Iftach Dolev, Ph.D. | CEO & Co-Founder, QuantalX Neuroscience

With the recent FDA De Novo clearance of our Delphi-MD™ system, a new clinical category has officially been established. This achievement not only validates years of relentless innovation but also marks the beginning of a new era in how brain health is evaluated and understood.

For decades, clinicians have relied on cognitive testing and structural imaging to piece together the puzzle of neurological health. Delphi-MD’s Functional Neuro-Imaging (FNI) test adds a new data dimension—direct, real-time measurements of brain function. By benchmarking patient data against an FDA-cleared normative database of healthy brain responses, physicians can rapidly assess neurological status and perform long-term evaluations of disease progression or treatment impact across diverse care settings.

This milestone is more than regulatory—it’s transformative. It positions QuantalX to accelerate global deployment, with a primary focus on U.S. commercial expansion. Our goal is to make precise, non-invasive brain-function assessments accessible across clinical environments, from academic medical centers to community hospitals. Delphi-MD™ bridges the gap between research and real-world care, bringing a new standard of functional brain insight directly to the point of care.

The establishment of FNI as a recognized clinical modality sets the stage for the next decade of innovation in brain healthcare. I’m immensely proud of our team, our collaborators, and the visionary clinicians who believed in this mission from the start.

Together, we are redefining what it means to see the brain in action.