QuantalX has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Delphi-MD neurodiagnostic device for normal pressure hydrocephalus (NPH).
The breakthrough designation was granted for use in the diagnosis of NPH patients and prediction of response to ventriculoperitoneal shunting surgery (VPS) treatment.
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The Delphi-MD system was designed to provide physicians with accessible neurodiagnostic capabilities at any point of care to facilitate enhanced outcomes related to brain health.
The breakthrough status was awarded based on positive preliminary clinical data.
The clinical data showed that the device provides better performance in the diagnosis of NPH and prediction of the effectiveness of shunt treatment, compared to the existing standard-of-care diagnostic procedure.
In June 2021, the Delphi-MD system received the breakthrough designation for the identification of patients who are at risk for dementia and stroke.
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By GlobalDataThis clinical application facilitates the early identification of abnormal changes in brain structure and function that could lead to stroke and dementia.
The device will enable objective measurement of neuronal functions to streamline the diagnosis process, enable earlier intervention and improve decision-making to select the right treatment.
QuantalX CEO and co-founder Dr Iftach Dolev said: “This second breakthrough designation status granted to Delphi-MD, focusing on NPH detection and treatment prediction is a major achievement and yet another reinforcement of our vision, providing a reliable tool for improved brain diagnosis and optimal personalised patient care.”
NPH is caused by the accumulation of cerebrospinal fluid (CSF) in the brain. It is characterised by walking difficulty, urgency and/or incontinence and cognitive decline.
The existing diagnostic procedure for the treatment of the condition includes cognitive evaluation, brain imaging through magnetic resonance imaging (MRI) or computerised tomography (CT) scanning and an assessment of mobility before and after the CSF tap test.
QuantalX stated that this evaluation process involves a significant risk of complications and is not reliable enough to accurately identify patients who are most likely to benefit from VPS surgery.
