{"id":47622,"date":"2026-01-28T15:06:47","date_gmt":"2026-01-28T15:06:47","guid":{"rendered":"https:\/\/ciaoup.it\/?p=47622"},"modified":"2026-01-28T15:06:47","modified_gmt":"2026-01-28T15:06:47","slug":"seno-medicals-next-generation-imagio-imaging-system-obtains-european-union-eu-medical-device-regulation-mdr-ce-mark-certification","status":"publish","type":"post","link":"https:\/\/ciaoup.it\/?p=47622","title":{"rendered":"Seno Medical’s Next-Generation Imagio\u00ae Imaging System Obtains European Union (EU) Medical Device Regulation (MDR) CE Mark Certification"},"content":{"rendered":"

COMUNICATO STAMPA – CONTENUTO PROMOZIONALE<\/p>\n

The CE Mark certification enables Seno Medical to market and sell the latest version of its Imagio\u00ae Imaging\u00a0System with\u00a0opto-acoustic, sound,\u00a0and artificial intelligence\u00a0in the European\u00a0Union.\u00a0<\/p>\n

SAN ANTONIO, Jan. 28, 2026 \/PRNewswire\/ — Seno Medical has received CE Mark certification for its next-generation Imagio\u00ae Imaging System, Model 9100.\u00a0EU\u00a0MDR\u00a0CE Mark indicates\u00a0that\u00a0a medical device meets the stringent safety, performance, and quality standards established globally, assessed by notified bodies approved for granting certification in the EU, and is mandatory for sale of product in the European Union and beyond.\u00a0<\/p>\n

“EU MDR certification is\u00a0one\u00a0of the most challenging regulatory processes, and we\u00a0are so pleased to have achieved this significant milestone for our most recent version of the Imagio\u00ae System,” commented\u00a0Tom\u00a0Umbel, CEO\u00a0of\u00a0Seno\u00a0Medical.\u00a0“Imagio\u00ae delivers\u00a0a\u00a0revolutionary\u00a0leap\u00a0forward\u00a0in patient care, and we are thrilled to be able to collaborate with our European colleagues to improve diagnostic processes for providers and patients.”\u00a0<\/p>\n

The\u00a0Imagio\u00ae System\u00a0helps\u00a0physicians,\u00a0facilities,\u00a0and other\u00a0qualified\u00a0healthcare providers differentiate\u00a0between benign\u00a0and\u00a0malignant breast\u00a0lesions\u00a0using a\u00a0novel\u00a0combination\u00a0of\u00a0artificial intelligence\u00a0(AI)\u00a0\u2013\u00a0SenoGram\u00ae,\u00a0ultrasound,\u00a0and\u00a0opto-acoustic\u00a0imaging technology\u00a0to\u00a0characterize\u00a0and differentiate\u00a0masses\u00a0that\u00a0may\u00a0\u2014\u00a0or\u00a0may\u00a0not\u00a0\u2014\u00a0require more\u00a0invasive\u00a0diagnostic\u00a0evaluation.\u00a0Seno Medical\u00a0received its\u00a0first\u00a0CE\u00a0Mark under MDD\u00a0in\u00a02014.\u00a0This\u00a0updated\u00a0market-optimized\u00a0design\u00a0of\u00a0the\u00a0Imagio\u00ae\u00a0Imaging System, Model 9100, utilizes\u00a0state-of-the-art\u00a0OA imaging\u00a0technology with native AI clinical decision support.\u00a0\u00a0<\/p>\n

Seno’s\u00a0Imagio\u00ae technology\u00a0combines\u00a0light, sound,\u00a0and\u00a0AI\u00a0to\u00a0deliver new\u00a0information\u00a0never before\u00a0available.\u00a0Opto-acoustic imaging is a new modality in medical imaging \u00a0that combines functional, anatomic, and morphologic information using light (laser optics or\u00a0opto-acoustics)\u00a0and\u00a0sound\u00a0waves\u00a0plus\u00a0proprietary\u00a0artificial intelligence\u00a0(SenoGram\u00ae)\u00a0to\u00a0produce\u00a0high-resolution,\u00a0high-contrast\u00a0images\u00a0with AI decision support for clinicians.\u00a0The\u00a0result\u00a0is\u00a0a\u00a0diagnostic functional\u00a0imaging modality\u00a0that increases diagnostic confidence.\u00a0<\/p>\n

Imagio\u00ae is non-invasive, has no ionizing radiation, does not use contrast agents, does not require the compression required in mammography, and does not have body habitus limitations as with MRI. Imagio\u00ae provides clinicians with real-time information and the ability to provide\u00a0same-day\u00a0results. Incorporating\u00a0Imagio\u00ae\u00a0into\u00a0a\u00a0center\u00a0can\u00a0improve workflow efficiency and help lower stress and anxiety in patients.\u00a0<\/p>\n

The\u00a0system is\u00a0indicated for\u00a0use\u00a0by\u00a0trained and qualified healthcare\u00a0providers\u00a0to evaluate\u00a0palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.\u00a0<\/p>\n

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company\u00a0committed to improving the efficiency \u2013 and reducing the complexity \u2013 of cancer diagnostics\u00a0through its\u00a0new modality: opto-acoustic\u00a0imaging. Approved by\u00a0the U.S. FDA in\u00a0January 2021, with supplemental approval in June 2022, Seno’s Imagio\u00ae Imaging System is a new modality combining light, sound, and integrated A.I. to provide information not previously available to clinicians. The result is substantially improved confidence in diagnostic results that leads to real-time assessments and streamlined care pathways. To learn more about Seno Medical’s Imagio\u00ae imaging technology and applications, visit\u00a0www.SenoMedical.com.\u00a0<\/p>\n

Contact:\u00a0Alex Hamlow,\u00a0(210)\u00a0615-6501, ahamlow@senomedical.com
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Logo – https:\/\/mma.prnewswire.com\/media\/2871134\/Seno_Medical_Logo.jpg
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Copyright 2026 PR Newswire. All Rights Reserved.\u00a0<\/p>\n

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COMUNICATO STAMPA – CONTENUTO PROMOZIONALE The CE Mark certification enables Seno Medical to market and…<\/p>\n","protected":false},"author":3,"featured_media":47623,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12],"tags":[23],"class_list":["post-47622","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-comunicati","tag-immediapress"],"_links":{"self":[{"href":"https:\/\/ciaoup.it\/index.php?rest_route=\/wp\/v2\/posts\/47622","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ciaoup.it\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ciaoup.it\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ciaoup.it\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/ciaoup.it\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=47622"}],"version-history":[{"count":1,"href":"https:\/\/ciaoup.it\/index.php?rest_route=\/wp\/v2\/posts\/47622\/revisions"}],"predecessor-version":[{"id":47653,"href":"https:\/\/ciaoup.it\/index.php?rest_route=\/wp\/v2\/posts\/47622\/revisions\/47653"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ciaoup.it\/index.php?rest_route=\/wp\/v2\/media\/47623"}],"wp:attachment":[{"href":"https:\/\/ciaoup.it\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=47622"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ciaoup.it\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=47622"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ciaoup.it\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=47622"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}