In a regulatory breakthrough for brain health diagnostics, Israeli company QuantalX Neuroscience announced this week that it has received De Novo authorization from the U.S. Food and Drug Administration for its Delphi-MD system, the first functional neuro-imaging (FNI) device cleared for routine clinical use.
The FDA granted the approval through its De Novo pathway, which applies to novel medical devices with no existing equivalent on the market. The designation not only permits commercial use of Delphi-MD in the United States but also establishes an entirely new regulatory category for brain function assessment tools.
Delphi-MD offers a non-invasive method for evaluating brain health by combining Transcranial Magnetic Stimulation (TMS) with electroencephalography (EEG). Patients wear a sensor-equipped EEG cap that records brain responses to magnetic pulses, producing a real-time “functional map” of brain network activity. Proprietary software then compares this data to an FDA-cleared internal database of healthy, age-matched brain responses.
The resulting report delivers clinically actionable insights, enabling physicians to monitor disease progression, evaluate treatment effects, and tailor neurological care. The test is radiation-free, requires no active participation from the patient, and can be administered without specialized infrastructure, making it suitable for various healthcare settings.
QuantalX says the system is already in clinical use at top Israeli hospitals including Sheba Medical Center, Tel Aviv Sourasky Medical Center, and Rabin Medical Center, as well as in private neurology practices. It is also being used in research at leading U.S. institutions such as Massachusetts General-Brigham, the University of Pennsylvania’s Traumatic Brain Injury Clinical Research Center, the University of Illinois Chicago, and the University of California, San Francisco.
In addition to FDA De Novo clearance, Delphi-MD is certified under the European Union’s CE-MDR regulation and approved by Israel’s Ministry of Health. It previously received FDA Breakthrough Device designation for its potential in assessing risk for stroke and dementia, as well as in diagnosis and treatment-response prediction for Normal Pressure Hydrocephalus (NPH).
“This is the first device cleared to directly measure responses across key central brain network hubs,” said Dr. Iftach Dolev, CEO and co-founder of QuantalX. “The system provides objective, accurate, and real-time information about each patient’s brain health. This milestone advances our mission to make precise neuro-functional assessment a routine part of clinical care and to fundamentally reshape how brain function is understood and evaluated today.”
Delphi-MD is now being deployed commercially in the U.S. and Europe, as QuantalX aims to make functional brain assessments a routine component of modern healthcare.