FDA Clears QuantalX Neuroscience’s Delphi Stimulator for Direct Brain Health Diagnosis

Iftach Dolev, PhD

(Credit: QuantalX)

According to a recent announcement, the FDA has granted clearance to QuantalX Neuroscience’s direct electrophysiological imaging device Delphi-MD, an innovative point-of-care neurodiagnostic platform, for its Delphi stimulator. The company noted that it will continue to work closely with healthcare providers to expand Delphi-MD's applicational use, aiming to ensure a potential transformative impact on neurodiagnostic practices.¹

Delphi-MD uses a high-resolution magnetic pulse to stimulate specific brain networks, measuring the resulting electrophysiological response. In healthy brain networks, this response demonstrates consistent patterns, while notable changes are observed in pathological states. This approach offers potential for early detection of brain abnormalities associated with various conditions, such as stroke, dementia (including Alzheimer, Lewy body disease, and vascular dementia), Parkinson disease, normal pressure hydrocephalus (NPH), traumatic brain injury, and general brain health assessment.

"We are thrilled and deeply honored to have received FDA clearance for Delphi-MD, as this milestone represents a significant validation of our commitment to delivering neurodiagnostic capabilities to any point of care through innovation," Iftach Dolev, PhD, CEO and co-founder at QuantalX, told told NeurologyLive^®. "It brings us closer to redefining how neurologists assess brain health by offering an objective, safe, and accurate test as a significant diagnostic tool, underscoring the potential of Delphi-MD to improve diagnostic accuracy, streamline care pathways, and ultimately enhance patient outcomes in neurological care."

The FDA has previously granted breakthrough designation device status twice to Delphi-MD, the first for the detection of patients at risk for stroke and dementia and the second for detection of NPH and prediction of treatment response to ventriculoperitoneal shunt surgery. The Delphi-MD platform also was selected for the agency’s Total Product Life Cycle Advisory program, supporting the company's efforts to advance the successful adoption of the technology in the United States healthcare market.² Furthermore, the Delphi-MD brain health assessment test had previously obtained a dedicated CPT reimbursement code, 0858T, from the American Medical Association.³

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"Delphi-MD stands out due to its unique non-invasive approach and the ability to directly measure neurophysiological responses at the brain network level, compared to a healthy brain database," Dolev added. "Unlike traditional imaging tools, Delphi-MD employs high resolution Focused Transcranial Magnetic Stimulation (fTMS) to elicit real-time evoked responses, providing a quantitative, functional assessment of brain connectivity and reactivity. Its portability, ease of use, and capability to generate actionable clinical insights at the point of care make it a game-changer in diagnosing and monitoring neurological conditions."

Findings from a recent study published in NPJ Parkinson’s Disease that used the direct electrophysiological imaging (Delphi-MD) technology demonstrated the occipital network involvement in early PD stages, suggesting that TMS-evoked potentials (TEPs) measures may offer insights into altered networks in PD subgroups.^4,5 In the study, investigators compared TEP measures from stimulation of bilateral motor cortex, dorsolateral prefrontal cortex, and visual cortex among 62 patients with PD and 76 healthy controls using a TMS-EEG protocol. Researchers divided the patients with PD were into tremor dominant, nontremor dominant and rapid disease progression subgroups.

Participants with PD displayed lower wide-waveform adherence (P = .025) and interhemispheric connectivity (P <.001) compared with healthy controls. Lower occipital interhemispheric connectivity correlated with advanced disease stage (r = -0.37; P = .0039). The rapid disease progression and nontremor dominant groups had lower wide-waveform adherence in response to occipital stimulation than the tremor dominant group (p = 0.005). Notably, occipital TEP measures identified patients who had rapid disease progression with 85% accuracy.

"Delphi-MD integrates seamlessly into existing clinical workflows. The process begins by entering patient information into the device’s user-friendly interface. Using Delphi's stimulating probe, the device ‘pings’ specific brain network hubs while simultaneously recording the evoked response via a sensor-laden cap," Dolev said. "The system automatically processes and analyzes the data, generating a detailed clinical report within minutes. This report provides quantitative insights into brain functionality and health, which clinicians can use to inform diagnoses, track disease progression, or evaluate treatment efficacy—all in a timely and efficient manner."

REFERENCES
1. QuantalX Secures FDA Clearance for its breakthrough Delphi stimulator, advancing direct brain health diagnosis at the point of care. News Release. Published November 12, 2024. Accessed January 3, 2024. https://quantalx.com/quantalx-secures-fda-clearance-for-its-breakthrough-delphi-stimulator-advancing-direct-brain-health-diagnosis-at-the-point-of-care/
2. QuantalX Secures Spot in FDA’s Prestigious Total Life Cycle Advisory Program (TAP). News Release. Published April 4, 2024. Accessed January 3, 2024. https://quantalx.com/quantalx-secures-spot-in-fdas-prestigious-total-life-cycle-advisory-program-tap/
3. QuantalX Secures Dedicated Reimbursement Code for Delphi-MD Test, Advancing Improved Brain Health. News Release. Published November 2, 2023. Accessed January 3, 2024. https://quantalx.com/quantalx-secures-dedicated-reimbursement-code-for-delphi-md-test-advancing-improved-brain-health/
4. Zifman N, Levy-Lamdan O, Hiller T, et al. TMS-evoked potentials unveil occipital network involvement in patients diagnosed with Parkinson's disease within 5 years of inclusion. NPJ Parkinsons Dis. 2024;10(1):182. Published 2024 Sep 30. doi:10.1038/s41531-024-00793-0
5. QuantalX Introduces a Breakthrough in the Diagnosis and Classification of Parkinson’s Disease. News Release. Published October 29, 2024. Accessed January 3, 2024. https://quantalx.com/delphi-md-revolutionizes-parkinsons-differential-diagnosis/