This article by Yoel Tsafrir was published by Haaretz Labels on January 9, 2024, in collaboration with QuantalX, and is reproduced here. It predates the FDA De Novo classification of Delphi-MD™.
QuantalX's team of neuroscientists developed a way to advance brain imaging and deliver neurological capabilities at the point of care, to enable real-time brain health measurements and promote early detection of abnormalities
The field of neurological care struggles with low efficiency attributed to delayed detection rates and frequent misdiagnosis. Neurological conditions are often detected and diagnosed only in their advanced stages, due to prevalent practices and ineffective tools, which include subjective cognitive testing, clinical impressions, and brain imaging like CT/MRI, that do not evaluate brain function. Late diagnosis and limited access to imaging tests contribute to suboptimal treatment choices, resulting in significant financial burden that accounts for about 35% of the total U.S.
healthcare expenditure.
The Delphi-MD is a pioneering, first-in-class medical device that provides objective and precise brain-function data using its novel direct electrophysiological imaging technology within a collaborative care model, incorporating neurologist supervision. This innovative device delivers real-time measures of brain network health directly to neurologists or primary care physicians at any point of care, marking a major milestone in neurodiagnosis: accessible, cost-effective, and safe preventive brain health.
The use of Delphi-MD ensures accurate early-stage disease diagnosis, delivering a dedicated clinical recommendations report to facilitate the right treatment selection for every patient. This eliminates trial and error, significantly improving patients' clinical outcomes, experience, and overall well-being. Delphi-MD promotes value-based brain health care, thereby reducing overall care costs for healthcare systems and payors, whilst mitigating risks associated with brain health issues.
This proprietary technology has been validated through multiple peer-reviewed studies, demonstrating efficacy in early detection and differential diagnosis of various neurological conditions such as Alzheimer's disease, Parkinson's, stroke, dementia, small vessel disease, traumatic brain injury, Normal Pressure Hydrocephalus (NPH), and longevity-related concerns.
This innovative device has received FDA Breakthrough Designation status twice: initially for early detection of stroke and dementia in high-risk patients, and subsequently for detecting and predicting treatment outcomes in NPH patients, a form of treatable dementia.
Delphi-MD is currently used by leading medical facilities in the US and Israel, experiencing increasing demand leading up to its planned 2024 commercial launch. Delphi-MD aims to redefine the standard of neurological care, ensuring that every patient, anywhere, can receive improved brain health care and experience a higher quality of life.
In collaboration with QuantalX
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