QuantalX Receives FDA De Novo Clearance for Delphi-MD™, Establishing a New Modality of Brain Function Assessment

The path-breaking technology empowers physicians to rapidly assess neurological health across diverse care settings by benchmarking patient data against a database of healthy brain responses.

New York, NY — QuantalX Neuroscience today announced that its Delphi-MD™ System, a first-of-its-kind functional neuro-imaging (FNI) device, has been granted FDA de novo classification, making it available for clinical practice. Physicians can now access a powerful clinical tool designed to benchmark brain health and function against a normal response database, monitor potential progression of neurological conditions, and assess how interventions may influence brain function.

“By unlocking direct insight into how the brain is functioning, Delphi-MD™ gives clinicians an essential piece of the brain evaluation puzzle alongside existing tools,” said Dr. Iftach Dolev, CEO and co-founder of QuantalX. “Delphi-MD™ is the first device cleared to deliver direct magnetic brain and measure the evoked responses across key brain network hubs. It incorporates a unique normative database, providing physicians with a comprehensive and age-dependent benchmark for assessing brain health. This milestone accelerates our mission to make precise, non-invasive neuro-functional assessment accessible in everyday care and to redefine how brain health is evaluated.”

QuantalX’s Delphi-MD™ combines a simple, non-invasive system of direct Transcranial Magnetic Stimulation (TMS) with electroencephalography (EEG). The EEG sensor array “cap” is fitted on a patient’s head and radiation-free magnetic stimulation creates an image of brain network function, controlled and analyzed by intelligent software. The software then gives clinicians a benchmarked comparison with a proprietary, FDA-cleared normative database of healthy adult brains of the same approximate age. The time from scan to report takes under an hour.

With Delphi-MD™, QuantalX is the first to combine TMS and EEG in an accessible device that produces clinically practical insights that are interpretable by a physician at a variety of clinical settings. Unlike traditional imaging, Delphi-M™’s functional neuro-imaging (FNI) technology provides new access into brain function including direct, causal insights.

“We are honored to work with the talented team at QuantalX and use Delphi-MD™ in our landmark ongoing study, the BrainHealth Project,” said Sandra Bond Chapman, PhD, Chief Director of the Center for BrainHealth at University of Texas at Dallas and Co-leader of the BrainHealth Project. “Direct and objective assessment of brain health is a critical element in the diagnostic process. The system can be an important and informative tool to measure brain health.”

The Delphi-MD™ system offers a cost-effective, ready-to-use solution that requires no specialized infrastructure and keeps operational costs low in clinical environments. Delphi-MD™ is currently in use for clinical research studies at Massachusetts General-Brigham; the University of Pennsylvania Traumatic Brain Injury Clinical Research Center; University of Illinois, Chicago; and the University of California, San Francisco Pain Management Center.

“The Delphi-MD™ approach uses EEG evoked potentials triggered by transcranial magnetic stimulation (TMS-EEG), and is an exciting technological breakthrough with potential applications across a broad range of neurologic disorders,” said Ramon Diaz-Arrastia, MD, PhD, Director of the Traumatic Brain Injury Clinical Research Center at UPenn Medicine.

The De Novo authorization follows QuantalX’s prior CE-MDR approval in Europe.

The system is now being deployed commercially in a number of medical centers in the US and Europe.

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About QuantalX Neuroscience

QuantalX Neuroscience is on a mission to help clinicians easily and early diagnose brain disorders; 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 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 regarding the commercially available device. Separate to the recent de novo clearance, FDA has also granted the Delphi-MD™ Breakthrough Device designation for detection of stroke and dementia, and detection and treatment prediction for NPH (Normal Pressure Hydrocephalus). The Delphi-MD™ is investigational for these conditions in further support of the company’s mission.

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