This article by Danny Sullivan was published by Longevity.Technology on February 17, 2026, and is reproduced here.
QuantalX Neuroscience leverages FDA De Novo clearance to launch non-invasive system for quantitative assessment of functional brain health.
Neurotech company QuantalX Neuroscience today announced the commercial launch of its Delphi MD brain function assessment system in the United States. Described as a “first-in-class” device, the non-invasive imaging platform is designed to measure how brain networks function in real time.
The launch follows the FDA’s recent De Novo classification of Delphi MD, creating a new regulatory category of functional brain network assessment technologies. The De Novo pathway allows technologies without a clear predicate to reach market if they demonstrate low-to-moderate risk and sufficient clinical evidence.
By combining transcranial magnetic stimulation with electroencephalography and AI-powered analytics, Delphi MD captures electrophysiological responses from targeted brain regions and compares the results with an age-correlated normative database, providing clinicians with metrics intended to help track changes in brain health over time. The system is designed to be used in a wide range of neurological and cognitive health contexts, from stroke and traumatic brain injury recovery to neuromodulation, pain management and, most interestingly from a longevity perspective, preventive brain health initiatives.
Having spent several years in use in research settings, QuantalX says it now aims to make neurofunctional testing part of routine clinical workflows. The company reports deployment has already begun at several academic and clinical centers in the United States, including programs at the University of Pennsylvania, Massachusetts General Hospital, the University of California San Francisco, the University of Texas at Dallas and others.
The Delphi MD assessment takes roughly 30 to 40 minutes to complete, and is designed to provide objective insights into brain function without requiring active patient participation during testing, providing clinicians with a standardized report intended to be measurable and easy to compare across visits. By quantifying functional responses, the platform aims to help clinicians identify subtle network changes that may not be visible through structural scans alone. Crucially, the test is covered by a dedicated Current Procedural Terminology reimbursement code to support billing.
“For decades, clinicians have relied primarily on structure and symptoms to guide neurological care,” said QuantalX CEO Dr Iftach Dolev. “Our commercialization in the US marks a critical step toward making functional brain assessment as routine and actionable as an EKG stress test.”
Photographs courtesy of QuantalX Neuroscience.
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