{"id":5110,"date":"2022-06-28T20:19:20","date_gmt":"2022-06-28T20:19:20","guid":{"rendered":"https:\/\/senomedical.com\/?p=5110"},"modified":"2025-06-16T20:19:52","modified_gmt":"2025-06-16T20:19:52","slug":"seno-medicals-market-ready-imagio-oa-us-breast-imaging-system-receives-supplemental-fda-pma-approval","status":"publish","type":"post","link":"https:\/\/senomedical.com\/index.php\/2022\/06\/28\/seno-medicals-market-ready-imagio-oa-us-breast-imaging-system-receives-supplemental-fda-pma-approval\/","title":{"rendered":"Seno Medical\u2019s Market-Ready Imagio\u00ae OA\/US Breast Imaging System Receives Supplemental FDA PMA Approval"},"content":{"rendered":"<p style=\"text-align: center;\"><i>The category-defining Imagio<sup>\u00ae<\/sup>\u00a0Breast Imaging System helps physicians\u00a0<\/i><br \/>\n<i>differentiate between benign and malignant breast lesions using a\u00a0<\/i><br \/>\n<i>novel combination of ultrasound and opto-acoustic technology.<\/i><\/p>\n<p>[SAN ANTONIO, TX \u2013\u00a0<strong>June 28, 2022<\/strong>] Seno Medical\u2019s Imagio<strong><sup>\u00ae<\/sup><\/strong>\u00a0Breast Imaging System, a revolutionary new modality in breast imaging, has received supplemental premarket approval (PMA) from the Center for Devices and Radiological Health (CDRH) of the US Food &amp; Drug Administration (FDA). Seno\u2019s market-ready, groundbreaking diagnostic breast cancer imaging system\u00a0helps physicians differentiate between benign and malignant breast lesions using non-invasive opto-acoustic\/ultrasound (OA\/US) technology to provide information on breast lesions in real time, helping providers to characterize and differentiate masses that may \u2014 or may not \u2014 require more invasive diagnostic evaluation.<\/p>\n<p>The Imagio<strong><sup>\u00ae<\/sup><\/strong>\u00a0Breast Imaging System incorporates state-of-the-art ultrasound imaging technology required for premier breast imaging centers, as well as advanced ultrasound technology integrated into the opto-acoustic probe, a new ultrasound probe, and elimination of redundant electronics, making this version of Imagio<strong><sup>\u00ae<\/sup><\/strong>\u00a0more ergonomic and truly disruptive for the marketplace with the latest technological advances.<\/p>\n<p>Tom Umbel, President and CEO of Seno Medical, commented, \u201cThis team is passionately committed to providing a revolutionary leap forward in patient care, and our commercial version of our Imagio<strong><sup>\u00ae<\/sup><\/strong>\u00a0System delivers just that. With our novel OA\/US platform, combined with the latest technologies available today in breast imaging, we are delivering a new hybrid modality that will help providers deliver the best care possible to their patients.\u201d<\/p>\n<p>The company is launching a mobile education and demonstration tour, Imagio<sup>\u00ae<\/sup>\u00a0OA\/US Road Show &#8211; Scans Across America, to enable on-site, hands-on demonstration with the Imagio<sup>\u00ae<\/sup>\u00a0System throughout the United States. The Imagio<sup>\u00ae<\/sup>\u00a0OA\/US Road Show &#8211; Scans Across America tour will begin in late July with continued stops across the country throughout 2022.<\/p>\n<p>Breast biopsy procedures, caused by false-positive diagnostic assessments, cost the US healthcare system more than $2 billion per year.<a href=\"https:\/\/senomedical.com\/newsroom\/press-releases\/P12#_edn1\"><sup>i<\/sup><\/a><sup>\u00a0<\/sup>Seno\u2019s Imagio<sup>\u00ae<\/sup>\u00a0technology could significantly reduce those costs with its non-invasive OA\/US innovation.<\/p>\n<p>Seno\u2019s OA\/US system combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer \u2014 angiogenesis and hypoxia \u2014 Seno Medical has shown that the Imagio<sup>\u00ae<\/sup><strong><sup>\u00a0<\/sup><\/strong>OA\/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared with traditional diagnostic imaging modalities. And it does this without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio<sup>\u00ae<\/sup>\u00a0System, Seno includes an artificial intelligence (AI) decision-support tool (SenoGram<sup>\u00ae<\/sup>) to aid physicians in interpreting the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA\/US imaging.<\/p>\n<p>The system is indicated for use by trained and qualified healthcare providers to evaluate palpable 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.<\/p>\n<p><strong>Seno Medical Instruments, Inc.<\/strong>\u00a0is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Originally approved by the US FDA in January 2021, Seno Medical\u2019s Imagio<sup>\u00ae<\/sup>\u00a0Breast Imaging System fuses opto-acoustic technology with ultrasound (OA\/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical\u2019s OA\/US imaging technology and applications, visit\u00a0<a href=\"http:\/\/www.senomedical.com\/\"><u>www.SenoMedical.com<\/u><\/a>.<\/p>\n<p style=\"text-align: center;\">###<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The category-defining Imagio\u00ae\u00a0Breast Imaging System helps physicians\u00a0 differentiate between benign and malignant breast lesions using a\u00a0 novel combination of ultrasound and opto-acoustic technology. [SAN ANTONIO, TX \u2013\u00a0June 28, 2022] Seno Medical\u2019s Imagio\u00ae\u00a0Breast Imaging System, a revolutionary new modality in breast imaging, has received supplemental premarket approval (PMA) from the Center for Devices and Radiological Health [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-5110","post","type-post","status-publish","format-standard","hentry","category-press-releases"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Seno Medical\u2019s Market-Ready Imagio\u00ae OA\/US Breast Imaging System Receives Supplemental FDA PMA Approval - Seno Medical<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/senomedical.com\/index.php\/2022\/06\/28\/seno-medicals-market-ready-imagio-oa-us-breast-imaging-system-receives-supplemental-fda-pma-approval\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Seno Medical\u2019s Market-Ready Imagio\u00ae OA\/US Breast Imaging System Receives Supplemental FDA PMA Approval - Seno Medical\" \/>\n<meta property=\"og:description\" content=\"The category-defining Imagio\u00ae\u00a0Breast Imaging System helps physicians\u00a0 differentiate between benign and malignant breast lesions using a\u00a0 novel combination of ultrasound and opto-acoustic technology. [SAN ANTONIO, TX \u2013\u00a0June 28, 2022] Seno Medical\u2019s Imagio\u00ae\u00a0Breast Imaging System, a revolutionary new modality in breast imaging, has received supplemental premarket approval (PMA) from the Center for Devices and Radiological Health [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/senomedical.com\/index.php\/2022\/06\/28\/seno-medicals-market-ready-imagio-oa-us-breast-imaging-system-receives-supplemental-fda-pma-approval\/\" \/>\n<meta property=\"og:site_name\" content=\"Seno Medical\" \/>\n<meta property=\"article:published_time\" content=\"2022-06-28T20:19:20+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-16T20:19:52+00:00\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/senomedical.com\/index.php\/2022\/06\/28\/seno-medicals-market-ready-imagio-oa-us-breast-imaging-system-receives-supplemental-fda-pma-approval\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/senomedical.com\/index.php\/2022\/06\/28\/seno-medicals-market-ready-imagio-oa-us-breast-imaging-system-receives-supplemental-fda-pma-approval\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\/\/senomedical.com\/#\/schema\/person\/e7a1b63d7cf22f013e61dd370eb4c3f7\"},\"headline\":\"Seno Medical\u2019s Market-Ready Imagio\u00ae OA\/US Breast Imaging System Receives Supplemental FDA PMA Approval\",\"datePublished\":\"2022-06-28T20:19:20+00:00\",\"dateModified\":\"2025-06-16T20:19:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/senomedical.com\/index.php\/2022\/06\/28\/seno-medicals-market-ready-imagio-oa-us-breast-imaging-system-receives-supplemental-fda-pma-approval\/\"},\"wordCount\":606,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/senomedical.com\/#organization\"},\"articleSection\":[\"Press Releases\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/senomedical.com\/index.php\/2022\/06\/28\/seno-medicals-market-ready-imagio-oa-us-breast-imaging-system-receives-supplemental-fda-pma-approval\/\",\"url\":\"https:\/\/senomedical.com\/index.php\/2022\/06\/28\/seno-medicals-market-ready-imagio-oa-us-breast-imaging-system-receives-supplemental-fda-pma-approval\/\",\"name\":\"Seno Medical\u2019s Market-Ready Imagio\u00ae OA\/US Breast Imaging System Receives Supplemental FDA PMA Approval - 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