Press Release

QuantalX™ Neuroscience Announces U.S. Commercialization of Delphi-MD™ Following FDA De Novo Classification

February 17, 2026
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3 min read
Delphi-MD system with a map of the United States

First‑in‑class functional brain network assessment enters routine clinical workflows at leading U.S. medical and research centers

New York – QuantalX™ Neuroscience today announced the U.S. commercialization of Delphi‑MD™, the company’s first‑in‑class, non‑invasive system for direct, quantitative assessment of functional brain networks. The expansion follows Delphi‑MD™’s recent FDA De Novo classification, which established a new regulatory category for functional brain network assessment and marks a shift from experimental neuroscience into routine clinical workflows.

Delphi‑MD™ is now being deployed across leading U.S. academic and clinical institutions, enabling neurologists, psychiatrists, neurosurgeons, and rehabilitation teams to access objective, real‑time measures of brain network function that complement traditional imaging and cognitive testing. The system combines transcranial magnetic stimulation (TMS) with electroencephalography (EEG), proprietary algorithm-based analytics, and an integrated age-correlated normative database to deliver objective, real-time, repeatable insights into functional brain health.

“For decades, clinicians have relied primarily on structure and symptoms to guide neurological care,” said Dr. Iftach Dolev, Founder & CEO of QuantalX™ Neuroscience. “With Delphi‑MD™, we are bringing objective, functional brain data into everyday clinical practice, giving care teams a direct, quantitative signal of how brain networks are actually performing. Our commercialization in the U.S. marks a critical step toward making functional brain assessment as routine and actionable as an EKG stress test.”

Led by Klaus Dahmen, Chief Commercial Officer of QuantalX™ Neuroscience, the company’s U.S. commercialization and deployment efforts are bringing Delphi-MD™ into prominent research and care centers, in order to support a broad range of neurological and cognitive health applications, including but not limited to:

  • Mount Sinai Health System, Enhanced Stroke Recovery Program
  • University of Pennsylvania, BrainSTIM Center
  • Mass General Brigham / Massachusetts General Hospital, Brain Recovery Lab
  • University of Pennsylvania, TBI Clinical Research Center
  • UCSF, Pain Management Center
  • Center for BrainHealth, University of Texas at Dallas
  • Nvivo Health, A Cardiocognitive InstituteTM, Beverly Hills
  • Brain Optimization Lab, Miami

Partners are applying Delphi-MD™ across a wide range of use cases, from stroke and Traumatic Brain Injury (TBI) recovery to neuromodulation, pain management, dementia, movement disorder, cognitive resilience, and preventive brain health, bringing real-time, objective brain function assessment into both clinical and research settings.

“We are proud to be collaborating with QuantalX as they bring Delphi-MD into the commercial market,” said Sandra Bond Chapman, PhD, Chief Director of the Center for BrainHealth at The University of Texas at Dallas. “In our ongoing BrainHealth Project, we’ve seen how essential direct and objective neuro-functional insights are to understanding brain health. Bringing this level of quantitative data into routine clinical workflows is a vital step toward proactive and personalized brain care.”

QuantalX™ Neuroscience will be showcasing Delphi-MD™ at two premier industry events this February:

  • ACNS 2026: From February 18–22, the team will engage with the neurosurgical and clinical neurophysiology communities at the American Clinical Neurophysiology Society (ACNS) Annual Meeting in New Orleans, LA, Booth #204, highlighting the platform’s technical depth and clinical data.
  • ViVE 2026: From February 22–25 in Los Angeles, CA, attendees can visit Booth #1953-1 to see firsthand how the first FDA De Novo–cleared platform for Direct Neuro-Functional Imaging is redefining brain health with real-time, actionable insights.

The non‑invasive evaluation is designed for use in routine clinical settings and can be completed in approximately 30–40 minutes. The standardized output report is measurable, repeatable, and easy to track over time. ​​Importantly, Delphi-MD™ evaluations are supported by a dedicated Current Procedural Terminology (CPT) reimbursement code, helping facilitate integration into routine clinical billing workflows. By comparing patient responses against a large, age‑correlated normative database that sets benchmarks, Delphi‑MD™ helps clinicians identify changes in brain network function and monitor trends across visits.

To learn more visit: https://quantalx.com/.

###About

QuantalX™ Neuroscience is on a mission to help clinicians diagnose brain disorders earlier and more easily, revolutionize the assessment of brain health, and bring functional neuro-imaging (FNI) to the point of care. With its Delphi‑MD™ path-breaking, first-of-its-kind, FDA-cleared system, QuantalX™ provides neurologists, neurosurgeons, and psychiatrists new access to the inner workings of the brain so they can make better-informed decisions about planning care for their patients. After years of use in groundbreaking research trials at institutions like UCSF, Mass General, and Penn, Delphi‑MD™ has received FDA De Novo clearance. Looking ahead, Delphi‑MD™ aims to enable continuous, real-world data generation on brain function over time, creating a proprietary dataset that can fuel intelligence-driven advancements in precision brain healthcare. Visit QuantalX.com to learn more about the commercially available device.