{"id":2918,"date":"2024-08-10T12:59:40","date_gmt":"2024-08-10T12:59:40","guid":{"rendered":"https:\/\/d.ptpl.dev\/acarix\/?page_id=2918"},"modified":"2026-05-15T10:58:45","modified_gmt":"2026-05-15T05:28:45","slug":"the-cadscor-system","status":"publish","type":"page","link":"https:\/\/d.ptpl.dev\/acarix\/the-cadscor-system\/","title":{"rendered":"The Cadscor System"},"content":{"rendered":"\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

CADScor\u00ae System: Overview<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

An advanced acoustic-based diagnostic aid to easily and quickly Risk Stratify significant coronary artery disease at point of care.*<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t<\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\tBook a CADScor\u00ae System demo<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t
\n\t\t\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t<\/div>\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Use CADScor\u00ae System to Determine if Chest Pain is Related to the Heart*<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

CADScor\u00aeSystem is a point-of-care diagnostic aid that uses highly sensitive acoustics and advanced computational processing to analyze the patient\u2019s coronary blood flow. The system calculates a patient-specific CAD-score, and couples it with risk factors to rapidly indicate the patient\u2019s risk of significant coronary stenosis for immediate risk stratification, prior to potential secondary evaluation.2\u00a0CADScor\u00aeSystem has been used in over 60,000 patient assessments3 and is CE-marked in accordance with EU MDR 2017\/745 and FDA De Novo clearance.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t<\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\tHow it works<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

CADScor System Uses Ultra-Sensitive Acoustics and Advanced Computational Processing to Rapidly Risk Stratify Coronary Artery Disease<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Non-invasive and radiation free assessment with actionable results<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\tCan help save costs of urgent advance CAD diagnostics in up to 40% of patients4<\/sup>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Allow for immediate risk stratification prior to potential secondary evaluation<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

An Individual CAD-score Indicates Low or Elevated Significant CAD Risk in Patients<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

The CAD-score is based on a phonocardiographic assessment, Advanced Computational <\/span>Processing <\/span>powered calculations and risk factors.\u00b9<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Low Risk<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

40% of patients are identified as low risk4<\/sup> by their CAD-score helping to streamline patient workflows. Seek alternative diagnosis for symptoms.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Elevated Risk<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Patient deemed elevated risk of significant CAD by their CAD-score. Refer for further followup.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t
\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

CADScor\u00ae System Research, Development and Clinical Studies<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

CADScor\u00ae System is based on 15+ years of R&D, covered by 45 patents, CE-marked in accordance with EU MDR 2017\/745 and has received FDA De Novo clearance as a diagnostic aid for symptomatic patients with suspected CAD. Multiple clinical studies with over 6,000 patients studied have been published to demonstrate CADScor\u00ae System\u2019s performance.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t<\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\tView Research<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Physicians\u2019 Experiences Using CADScor\u00ae System<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t<\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\tExplore customer feedback<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
  1. Winther S, et al. Heart 2018;104:928\u2013935 (Dan-NICAD I)<\/em><\/small><\/li>
  2. User manual US-FDA v.12.Y, prevalence 10,7%<\/small><\/li>
  3. Based on commercial patch use since 2017<\/em><\/small><\/li>
  4. Bjerking LH et al.Eur Heart J. Published online September 1, 2024<\/em><\/small><\/li><\/ol>

    *Risk Stratify with at least 96% confidence (NPV)<\/em><\/small><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

    \n\t\t\t\t\t
    \n\t\t
    \n\t\t\t\t
    \n\t\t\t\t
    \n\t\t\t\t\t

    Important Safety
    Information<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
    \n\t\t\t\t
    \n\t\t\t\t
    \n\t\t\t\t\t\t\t
    \n\t\t\t\t\t\t\t
    \n\t\t\t\t\t
    \n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tIntended Use<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

    The intended use of the CADScor\u00aeSystem is to record heart sounds, i.e. murmurs and vibration for calculation of a patient specific score, the CAD-score, indicating the risk of coronary stenosis, as an aid in cardiac analysis and diagnosis.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

    \n\t\t\t\t\t
    \n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tIndications for use<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

    The CADScor\u00aeSystem is indicated for use as a diagnostic aid in symptomatic patients suspected of stable Coronary Artery Disease\/Chronic Coronary Syndrome.<\/p>

    Symptoms of CAD\/CCS may manifest as*
    Typical angina symptoms;
    <\/strong>(all three below)
    \u2022 Sub-sternal chest discomfort of characteristic quality and duration
    \u2022 Provoked by exertion or emotional stress;
    \u2022 Relieved by rest and\/or nitrates within minutes.<\/p>

    Atypical angina symptoms;
    <\/strong>(Two of the above)<\/p>

    Non-anginal chest pain;
    <\/strong>Lacks or meets only one or none of the above characteristics.<\/p>

    Dyspnea\/breathlessness
    <\/strong>*as defined by ESC Guidelines 2019 &NICE UK Guidelines CG95, 2019<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

    \n\t\t\t\t\t
    \n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tWarnings<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

    Warnings are alerts described to alert and reduce the risk of death or serious injury from use of the CADScor\u00aeSystem.<\/p>

    Warnings and precautions are labelled with a warning triangle and also refers to the relevant section in the User Manual.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

    \n\t\t\t\t\t
    \n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tPatient and user risk warnings<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

    Do not use the CADScor\u00aeSystem without the necessary qualifications, and only after instruction and having read and understood this User-Manual, including, symbols, contra-indications, warnings and precautions, due to risk of death or serious injury.<\/p>

    Do not use the CADScor\u00aeSystem on patients with implanted electronics like ICD, Pacemakers, heart-pumps closer than 50 cm to similar active electronic support equipment, due to risk of equipment failure from CADScor\u00aeSystem electromagnetic RFID impulse.<\/p>

    Do not attempt to re-use a CADScor\u00aePatch. The patch is single use only for hygienic reasons, to prevent possible cross contamination\/infection between patients.<\/p>

    The CADScor\u00aeSystem and patches are MRI-unsafe and should not be operated or placed in a Magnetic Resonance Imaging (MRI-) room, due to risk of skin burns and\/or magnetic attraction and impact.<\/p>

    Never use other power adaptor than supplied with the CADScor\u00aeSystem, due to risk of electrical shock.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

    \n\t\t\t\t\t
    \n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tPrecautions<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

    Precautions are alerts to reduce potentially hazardous situations or risks of nonserious injury or reduced effectiveness from use of the CADScor\u00aeSystem.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

    \n\t\t\t\t\t
    \n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tRisk of incorrect CAD-score<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

    Incorrect placement of the CADScor\u00ae Sensor, outside patient IC4-L, may result in an incorrect CAD-score.<\/p>

    Inform patients who have CAD-score \u226420 to seek medical attention if symptoms persist or worsen after initial evaluation\u201d, due to the risk of a false negative CADScor result.<\/p>

    The CAD-scores from patients in the 30-39-year group are currently outside the intended patient population. A warning triangle indicates the higher uncertainty of their CAD-score.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

    \n\t\t\t\t\t
    \n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tRisk of damage to the CADScor\u00ae System<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t
    <\/main>

    Do not touch the charge-point terminals on the CADScor\u00aeSystem, due to risk of permanent damage to the electronics inside by electrostatic discharge.<\/p>

    Do not drop or exert excessive force to the CADScor\u00aeSystem since this may<\/p>

    damage the CADScor\u00aeSystem permanently.<\/p>

    Do not expose the CADScor\u00aeSystem to liquids (water, oils, detergents or similar) or dust, since this may damage the CADScor\u00aeSystem permanently.<\/p>

    The CADScor\u00aeSystem cannot be heator radiation sterilized, or machine washed\/cleaned, since this may damage the CADScor\u00aeSystem permanently.<\/p>

    Do not modify the CADScor\u00aeSystem or use or repair a defect CADScor\u00aeSystem, due to risk of malfunctioning. The CADScor\u00aeSystem must only be serviced by qualified Acarix personnel.<\/p><\/div><\/section><\/div><\/div><\/div><\/section><\/section><\/div><\/div>