{"id":2935,"date":"2024-08-10T13:08:37","date_gmt":"2024-08-10T13:08:37","guid":{"rendered":"https:\/\/d.ptpl.dev\/acarix\/?page_id=2935"},"modified":"2026-05-05T16:48:03","modified_gmt":"2026-05-05T11:18:03","slug":"faq","status":"publish","type":"page","link":"https:\/\/d.ptpl.dev\/acarix\/faq\/","title":{"rendered":"Faq"},"content":{"rendered":"\t\t
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Frequently Asked Questions<\/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
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CADScor\u00ae System Questions<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\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\tHow can I use the CADScor\u00ae System?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

The intended use of CADScor\u00aeSystem is to record heart sounds, i.e., murmurs and vibrations, for calculation of a patient-specific score, the CAD-score, indicating the risk of coronary stenosis, as an aid in cardiac analysis and diagnosis. We suggest using CADScor\u00aeSystem as a first-line non-invasive diagnostic aid to help rule out significant CAD in patients suspected of stable CAD. This may limit the need for further downstream testing and invasive diagnostic procedures. A patient with a low CAD-score (\u226420) is unlikely to have CAD. A patient with an elevated CAD-score (>20) has an increased likelihood of disease and should be followed more closely or referred for further evaluation.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\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\tDoes the CADScor\u00ae System have regulatory authorization in Europe and the united States?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

The CADScor\u00ae System is CE-marked in Europe and has been commercially marketed since Q2 2017. The system achieved EU MDR (Regulation (EU) 2017\/745) certification in 2026, confirming continued conformity under the MDR framework. In the United States, the CADScor\u00ae System received FDA De Novo clearance in November 2020.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\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\tIn which countries is the CADScor\u00ae System used?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

Currently (beginning of\u00a02022)\u00a0CADScor\u00aeSystem\u00a0is used in Denmark, Sweden, Germany, Austria, Switzerland, Luxemburg, UK and USA.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\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\tHow is the CADScor\u00ae System classified under EU MDR and FDA regulations?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

In Europe, the CADScor\u00ae System is classified as a Class IIa medical device under Regulation (EU) 2017\/745 (EU MDR) and is CE-marked accordingly. In the United States, the CADScor\u00ae System is classified as a Class II medical device.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\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\tWhat do I do when the battery is low?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

The system will indicate if the battery is low. The battery drain is significant during qualifications. Charging it for 15 minutes is sufficient for a couple of recordings, 30 minutes for approximately 10 recordings. Always have docking station plugged in and sensor should be returned to docking station when not in use.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\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\tCan I talk to my patient during the recording phase?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

Guiding the patient during the CAD-score evaluation is essential. Two parts of each recording loop exist, one in which the patient is breathing normally and one in which the patient will hold their breath. No talking (or noisy behavior) can occur during the breath-holding period.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\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\tCan patches be re-used?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

No. The patch contains a specific chip and code that is needed to calibrate the machine and will indicate when the patch has been used.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\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\tWhere should I dispose used patches?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

\u00a0<\/p>

Dispose of used patches together with other standard clinical waste.<\/p><\/div><\/section><\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\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\tWhat are the primary CADScor\u00ae System studies?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

The clinical program behind CADScor\u00aeSystem is comprehensive, with the Adopt CAD, BIO-CAC and Dan-NICAD clinical studies with 2,591 patients forming the basis for CE marking and FDA De Novo clearance. Overall, the clinical studies include 8,000 patients, of which 6,800 are in the clinical development program. Additional studies are underway to further strengthen the performance metrics and the algorithm and expand the product portfolio.
View Acarix Clinical Studies<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\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

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Contact Us<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Please visit our contact page to get in touch.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Frequently Asked Questions CADScor\u00ae System Questions How can I use the CADScor\u00ae System? The intended use of CADScor\u00aeSystem is to<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-2935","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nAcarix | Frequently Asked Questions<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Acarix | Frequently Asked Questions\" \/>\n<meta property=\"og:description\" content=\"Frequently Asked Questions CADScor\u00ae System Questions How can I use the CADScor\u00ae System? 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