{"id":8589,"date":"2025-03-07T12:38:00","date_gmt":"2025-03-07T11:38:00","guid":{"rendered":"https:\/\/www.mirdetect.de\/?p=8589"},"modified":"2025-10-21T13:03:20","modified_gmt":"2025-10-21T11:03:20","slug":"u-s-fda-breakthrough-device-designation","status":"publish","type":"post","link":"https:\/\/www.mirdetect.de\/en\/u-s-fda-breakthrough-device-designation\/","title":{"rendered":"Breakthrough Device Designation"},"content":{"rendered":"
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Bremerhaven, 7 March 2025<\/strong> - mir|detect GmbH announced today that the U.S. Food and Drug Administration (FDA)<\/strong> the M371-Test<\/strong> the Breakthrough Device Designation<\/strong> has issued. The M371-Test<\/strong> is a new type of Liquid Biopsy<\/strong> for the precise and non-invasive detection of Testicular cancer<\/strong>.<\/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

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Significance of the Breakthrough Device Designation<\/h5>\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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The Breakthrough Device Designation<\/strong> is one of the FDA's highest designations for medical devices. It is only awarded to products that have the potential to significantly improve the diagnosis or treatment of serious diseases.<\/p>\n

With this award, the FDA recognises the M371-Test<\/strong> as a pioneering diagnostic tool that can significantly improve the detection and monitoring of testicular cancer.<\/p>\nThe Breakthrough Device Programme<\/strong> enables companies to obtain accelerated and closely supervised authorisation. It offers:
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  • Prioritised review by the FDA<\/li>\n \t
  • Early and direct exchange with FDA experts<\/li>\n \t
  • Shortened decision-making processes for faster market access<\/li>\n<\/ul>\n
    \nThe programme thus specifically supports technologies that offer real progress for patients with urgent medical needs.\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
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    About the M371-Test<\/h5>\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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    Testicular cancer is the most common cancer in young men. Early and reliable diagnosis is crucial for successful treatment. The M371-Test<\/strong> utilises circulating microRNA biomarkers for the highly sensitive and specific determination of miR-371a-3p<\/strong>a biomarker that is expressed exclusively in testicular germ cell tumours.<\/p>

    Clinical studies show that the M371-Test<\/strong> is clearly superior to traditional serum tumour markers and enables more accurate, non-invasive diagnostics.<\/p>

    Key advantages of the M371-Test:<\/strong><\/p>

    • Non-invasive: detection of testicular cancer using a simple blood sample<\/li>
    • Higher diagnostic accuracy: outperforms classic serum tumour markers<\/li>
    • Improved follow-up: Supports the assessment of therapy response and relapses<\/li><\/ul>

      \u00a0<\/p>

      \"This Breakthrough Device Designation is an important milestone for mir|detect and a clear endorsement of our technology,\" said Dr Nina Winter, CEO at mir|detect. mir|detect<\/strong>. \"The close cooperation with the FDA enables us to M371-Test<\/strong> more quickly in the USA and thus improve the diagnosis of testicular cancer in the long term.\"<\/p>

      With the inclusion in the Breakthrough Device Programme<\/strong> Profits mir|detect<\/strong> of prioritised regulatory processes and direct access to FDA expertise - a decisive step on the way to market approval in the United States.<\/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\t\t<\/div>","protected":false},"excerpt":{"rendered":"

      Bremerhaven, 7. M\u00e4rz 2025 – Die mir|detect GmbH gab heute bekannt, dass die U.S. Food and Drug Administration (FDA) dem M371-Test die Breakthrough Device Designation erteilt hat. Der M371-Test ist eine neuartige Liquid Biopsy zur pr\u00e4zisen und nicht-invasiven Erkennung von Hodenkrebs. Bedeutung der Breakthrough Device Designation Die Breakthrough Device Designation ist eine der h\u00f6chsten Anerkennungen […]<\/p>\n","protected":false},"author":10,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":"","_wp_rev_ctl_limit":""},"categories":[1],"tags":[],"class_list":["post-8589","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"\nBreakthrough Device Designation - mir|detect<\/title>\n<meta name=\"description\" content=\"mir|detect erh\u00e4lt FDA Breakthrough Device Designation f\u00fcr den M371-Test zur pr\u00e4zisen, nicht-invasiven Erkennung von Hodenkrebs.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.mirdetect.de\/en\/u-s-fda-breakthrough-device-designation\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Breakthrough Device Designation - 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