QUANTALX


Associated tags: Health, Stroke, FDA, Physician, Medical imaging, Dementia, Patient, NPH, Entrepreneurship, Delphi, Quality of life, Pharmaceutical industry, VPS, Brain, CT, Diagnosis, MRI, DSM-IV codes, Neurology

Locations: NYC, NEW YORK, UNITED STATES OF AMERICA, ISRAEL

QuantalX Secures Spot in FDA's Prestigious Total Life Cycle Advisory Program (TAP)

Retrieved on: 
Thursday, April 4, 2024
Diagnosis, NPH, Movement disorder, Growth, Cerebrospinal fluid, CSF, Risk, Patient, DSM-IV codes, Stroke, TAP, Doctor of Philosophy, Medtronic, Science, Approximation error, Normal pressure hydrocephalus, Food, FDA, VPS, Dementia, Pharmaceutical industry

NEW YORK, April 4, 2024 /PRNewswire/ -- QuantalX Neuroscience, a pioneering healthcare company dedicated to early detection of brain disorders using the Delphi-MD medical device, announced today its selection to participate in the highly prestigious Total Life Cycle Advisory Program (TAP) initiated by the U.S. Food and Drug Administration (FDA). The program will focus on advancing Delphi-MD's unique Direct Electrophysiology Imaging technology, enabling the early detection of Normal Pressure Hydrocephalus (NPH) disease, with high accuracy rates, and the prediction of patients' response to ventriculoperitoneal shunting (VPS). The TAP program brings together the FDA, major health insurers, healthcare organizations, and industry leaders in a collaborative effort to construct a comprehensive strategy for technologies that can benefit the general population. This strategic framework spans crucial elements, such as value creation in the U.S. market, meticulous preparation for regulatory approval, meaningful engagement with insurers, and the establishment of a robust market presence with customers.

Key Points: 
  • NEW YORK, April 4, 2024 /PRNewswire/ -- QuantalX Neuroscience, a pioneering healthcare company dedicated to early detection of brain disorders using the Delphi-MD medical device, announced today its selection to participate in the highly prestigious Total Life Cycle Advisory Program (TAP) initiated by the U.S. Food and Drug Administration (FDA).
  • "The acceptance into the Total Life Cycle Advisory Program is a truly prestigious and significant opportunity for QuantalX," remarked Iftach Dolev.
  • The Total Life Cycle Advisory Program aims to guide innovative technologies through the entire product life cycle, ensuring regulatory compliance, market adoption, and enhanced positive patient impact.
  • The valuable experience and insights within this program are expected to accelerate QuantalX's market entry and establish a solid foundation for future growth.

QuantalX Secures Dedicated Reimbursement Code for Delphi-MD Test, Advancing Improved Brain Health

Retrieved on: 
Thursday, November 2, 2023
Stroke, FDA, MRI, Medicare, Neurology, American Medical Association, Physician, Breakthrough, Doctor of Philosophy, Health, Dementia, AMA, DSM-IV codes, Caregiver, Myenteric plexus, NPH, Risk, CT, Brain, CPT, Patient, VPS, Pharmaceutical industry, Medical imaging

NEW YORK, Nov. 2, 2023 /PRNewswire/ -- QuantalX Neuroscience, a pioneering healthcare company dedicated to early detection of brain disorders, is pleased to announce that it has secured a US reimbursement code, 0858T, from the American Medical Association (AMA). This milestone achievement is a significant part of the company's pre-commercialization strategy in the US.

Key Points: 
  • QuantalX announces the authorization of a dedicated US reimbursement code for its point-of-care brain health test by the American Medical Association (AMA).
  • NEW YORK, Nov. 2, 2023 /PRNewswire/ -- QuantalX Neuroscience , a pioneering healthcare company dedicated to early detection of brain disorders, is pleased to announce that it has secured a US reimbursement code, 0858T, from the American Medical Association (AMA).
  • The newly assigned CPT code signifies Delphi-MD's importance in early brain health assessment, catering to brain health evaluation procedures at any clinical setting using a collaborative care model.
  • The Delphi-MD technology is  a first-in-class automated, Direct Neuro-Physiological technology to detect and assess brain abnormalities, as well as predict treatment response.

QuantalX Receives FDA Breakthrough Designation for Diagnosis of Normal Pressure Hydrocephalus and Prediction of Treatment Response

Retrieved on: 
Tuesday, May 30, 2023
CT, Vascular dementia, Prevalence, Shunt (electrical), DSM-IV codes, Stroke, Quality of life, Alzheimer's disease, Delphi, Cerebrospinal fluid, Dementia, KFAR, MRI, Science, Medtronic, Walking, VPS, Parkinson's disease, Patient, Risk, Physician, Diagnosis, Entrepreneurship, CSF, FDA, Health, NPH, Pharmaceutical industry, Medical imaging, Neuromodulation

KFAR SABA, Israel, May 30, 2023 /PRNewswire/ -- QuantalX, the developer of Delphi-MD, a novel point-of-care neurodiagnostic device, has announced that they have received the prestigious FDA breakthrough designation medical device status for another clinical application, Normal Pressure Hydrocephalus (NPH). The FDA recognized the innovative value of the device in diagnosing NPH patients and predicting the response to the recommended treatment for NPH, ventriculoperitoneal shunting (VPS) surgery.

Key Points: 
  • The FDA grants the Delphi-MD device breakthrough designation technology status for the diagnosis of Normal Pressure Hydrocephalus (NPH) patients and prediction of response to highly effective, ventriculoperitoneal shunting surgery (VPS) treatment.
  • KFAR SABA, Israel, May 30, 2023 /PRNewswire/ -- QuantalX, the developer of Delphi-MD, a novel point-of-care neurodiagnostic device, has announced that they have received the prestigious FDA breakthrough designation medical device status for another clinical application, Normal Pressure Hydrocephalus (NPH).
  • The FDA recognized the innovative value of the device in diagnosing NPH patients and predicting the response to the recommended treatment for NPH, ventriculoperitoneal shunting (VPS) surgery.
  • This marks the second time that the Delphi-MD device has been granted a breakthrough designated medical device by the FDA.

Delphi-MD Breakthrough diagnostic technology promises to reduce healthcare burden by detecting brain abnormalities prior to symptoms, at the point of care

Retrieved on: 
Monday, November 14, 2022
Health, Quality of life, Neurology, Technology, Cardiovascular disease, Neuro, Patient, Impact, Figure, Rehabilitation, UCLA, Physician, Behavior, Hospital, FDA, Entrepreneurship, Manisha Girotra, Delphi, World, Lancet, CEO, UCLA IMG Program, Brain, Diagnosis, AHA, Medical imaging, Stroke, Dementia

RAANANA, Israel, Nov. 14, 2022 /PRNewswire/ -- QuantalX developer of Delphi-MD, an "ECG" for the brain, showcases its brain health revolutionizing technology at the HLTH Las Vegas conference for the first time as part of its US commercialization efforts towards expected FDA breakthrough path clearance.

Key Points: 
  • For patients, an earlier diagnosis leads to an optimal care pathway, resulting in a positive, long-term effect on quality of life.
  • Recent estimations* show the financial burden of stroke and dementia care alone to exceed $550B/ year in the US alone.
  • "Making neuro-diagnosis accessible to everyone is game changing for brain health management"
    "I am very excited by QuantalX's Delphi-MD technology.
  • The Delphi-MD device solves current neurology diagnostic challenges through a direct neuro diagnosis, novel technology, revolutionizing brain health standard of care as we know it.