{"id":815279,"date":"2025-02-20T03:03:13","date_gmt":"2025-02-20T08:03:13","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\/"},"modified":"2025-02-20T03:03:13","modified_gmt":"2025-02-20T08:03:13","slug":"hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\/","title":{"rendered":"Hologic Obtains CE Mark for Affirm\u00ae Contrast Biopsy Software"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Hologic Obtains CE Mark for Affirm<sup>\u00ae<\/sup> Contrast Biopsy Software<\/b><\/p>\n<p class=\"bwalignc\"><i>Innovative Technology Allows Clinicians to Target and Acquire Tissue Samples Using Contrast-Enhanced Mammography<\/i><\/p>\n<p>MARLBOROUGH, Mass.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nGlobal women\u2019s health leader Hologic, Inc. (Nasdaq: HOLX) today announced that its Affirm<sup>\u00ae <\/sup>Contrast Biopsy Software, which combines contrast-enhanced diagnostic capabilities with accurate lesion targeting to help streamline workflow and accelerate biopsy procedures,<sup>1-2<\/sup> is now CE-marked. The technology received clearance from the U.S. Food and Drug Administration in October 2020.\n<\/p>\n<p>\nDesigned from the ground up to integrate with the Selenia<sup>\u00ae<\/sup> Dimensions<sup>\u00ae<\/sup> and 3Dimensions\u2122 systems, Hologic\u2019s Affirm Contrast Biopsy Software enables clinicians to target and acquire tissue samples in lesions identified through contrast-enhanced mammography (CEM).\n<\/p>\n<p>\n\u201cAt Hologic, we are committed to helping women live healthier lives everywhere, every day, including through innovative technologies that support the detection and diagnosis of breast cancer,\u201d said Tanja Brycker, Vice President of International Strategic Development for Breast &amp; Skeletal Health and Gynecological Surgical Solutions at Hologic. \u201cWe understand the pressures that radiologists work under and the impact that the breast screening and diagnosis process can have on women. Our new Affirm Contrast Biopsy solution is designed to support radiologists by maximizing workflow efficiencies while helping them to continue to deliver compassionate patient care.\u201d\n<\/p>\n<p>\nThe software allows the targeting and acquisition of tissue samples in lesions identified on CEM where a correlation may not be found using tomosynthesis or ultrasound, offering an alternative to MRI-guided biopsy. In addition, for those patients who cannot tolerate MRI-guided biopsies, contrast-enhanced biopsy provides a smooth examination experience due to reduced noise and shorter examination time compared with MRI.<sup>3<\/sup> Ultimately, contrast-enhanced biopsy has the potential to help save time, reduce costs and improve patient experience.<sup>1<\/sup><\/p>\n<p>\nWith Hologic\u2019s powerful contrast mammography and biopsy portfolio \u2014 including the Affirm Upright Biopsy System, I-View<sup>\u00ae<\/sup> 2.0 Contrast-Enhanced Mammography Software and Affirm Contrast Biopsy Software \u2014 the company provides solutions to confidently guide the clinical pathway from screening to diagnosis and biopsy.\n<\/p>\n<p>\nFor more information, please visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.hologic.co.uk%2Fen-gb%2Fproducts%2Fscreening-and-diagnosis-solution&amp;esheet=54210370&amp;newsitemid=20250220676235&amp;lan=en-US&amp;anchor=Hologic+UK+Screening+%26amp%3B+Diagnosis+Solution&amp;index=1&amp;md5=ccbf370d88ddab41bf3770f38f8c7141\">Hologic UK Screening &amp; Diagnosis Solution<\/a>.\n<\/p>\n<p><b>About Hologic, Inc.<\/b><\/p>\n<p>\nHologic, Inc. is a global leader in women\u2019s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.hologic.com&amp;esheet=54210370&amp;newsitemid=20250220676235&amp;lan=en-US&amp;anchor=www.hologic.com&amp;index=2&amp;md5=9cb336776ceefeae1157413e1eafbf0d\">www.hologic.com<\/a> and connect with us on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fhologic%2F&amp;esheet=54210370&amp;newsitemid=20250220676235&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=3&amp;md5=3dee6e61a8e6a064392386ed261d3ee7\">LinkedIn<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2FHologic&amp;esheet=54210370&amp;newsitemid=20250220676235&amp;lan=en-US&amp;anchor=Facebook&amp;index=4&amp;md5=f05cbd6f6d556b1a930ac12e7ad1a299\">Facebook<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2FHologic&amp;esheet=54210370&amp;newsitemid=20250220676235&amp;lan=en-US&amp;anchor=X%2C&amp;index=5&amp;md5=fb49693521bba0abb4b638361b9bd6eb\">X,<\/a><a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.instagram.com%2Fhologic%3Futm_source%3Dig_web_button_share_sheet%26igsh%3DZDNlZDc0MzIxNw%3D%3D&amp;esheet=54210370&amp;newsitemid=20250220676235&amp;lan=en-US&amp;anchor=Instagram&amp;index=6&amp;md5=7072960be66db854e6625e4d4871b137\">Instagram<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.youtube.com%2Fchannel%2FUChrzlPhyLwmBUgjFAUHc0qQ&amp;esheet=54210370&amp;newsitemid=20250220676235&amp;lan=en-US&amp;anchor=YouTube&amp;index=7&amp;md5=fb9d14dbb45b6c1170fb9a7f18b6417c\">YouTube<\/a>.\n<\/p>\n<p><b>Forward-Looking Statements<\/b><\/p>\n<p>\nThis news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.\n<\/p>\n<p>\nThis information is not intended as a product solicitation or promotion where such activities are prohibited. For specific information on what products are available for sale in a particular country, please contact a local Hologic sales representative or write to <a rel=\"nofollow\" href=\"mailto:womenshealth@hologic.com\">womenshealth@hologic.com<\/a>.\n<\/p>\n<p>\nHologic, The Science of Sure, 3Dimensions, Affirm, Dimensions, I-View and Selenia are trademarks and\/or registered trademarks of Hologic, Inc., and\/or its subsidiaries in the United States and\/or other countries.\n<\/p>\n<p><b>References<\/b><\/p>\n<p><sup>1 <\/sup>Hologic Data on File. Affirm Contrast Biopsy Instructions for Use. MAN-07748 Rev 002.<br \/>\n<br \/><sup>2 <\/sup>Schrading S, Distelmaier M, Dirrichs T, et al. Digital breast tomosynthesis-guided vacuum-assisted breast biopsy: initial experiences and comparison with prone stereotactic vacuum-assisted biopsy. Radiology. 2015;274(3):654-62.<br \/>\n<br \/><sup>3 <\/sup>Compared to MRI procedures.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250220676235r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20250220676235\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20250220676235\/en\/<\/a><\/span><\/p>\n<p><b>Media Contact<br \/>\n<\/b><br \/>Bridget Perry<br \/>\n<br \/>Senior Director, Corporate Communications<br \/>\n<br \/>(+1) 508.263.8654<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:bridget.perry@hologic.com\">bridget.perry@hologic.com<\/a><\/p>\n<p><b>Investor Contact<br \/>\n<\/b><br \/>Michael Watts<br \/>\n<br \/>Corporate Vice President, Investor Relations<br \/>\n<br \/>(+1) 858.410.8514<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:michael.watts@hologic.com\">michael.watts@hologic.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> Europe United States North America Massachusetts<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Women Software Oncology Health Medical Devices Health Technology Technology Consumer<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250220676235\/en\/718080\/3\/Hologic_Main_Logo_Small_White_cropped.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Hologic Obtains CE Mark for Affirm\u00ae Contrast Biopsy Software Innovative Technology Allows Clinicians to Target and Acquire Tissue Samples Using Contrast-Enhanced Mammography MARLBOROUGH, Mass.&#8211;(BUSINESS WIRE)&#8211; Global women\u2019s health leader Hologic, Inc. (Nasdaq: HOLX) today announced that its Affirm\u00ae Contrast Biopsy Software, which combines contrast-enhanced diagnostic capabilities with accurate lesion targeting to help streamline workflow and accelerate biopsy procedures,1-2 is now CE-marked. The technology received clearance from the U.S. Food and Drug Administration in October 2020. Designed from the ground up to integrate with the Selenia\u00ae Dimensions\u00ae and 3Dimensions\u2122 systems, Hologic\u2019s Affirm Contrast Biopsy Software enables clinicians to target and acquire tissue samples in lesions identified through contrast-enhanced mammography (CEM). \u201cAt Hologic, we are committed to helping women live healthier lives &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Hologic Obtains CE Mark for Affirm\u00ae Contrast Biopsy Software&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-815279","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Hologic Obtains CE Mark for Affirm\u00ae Contrast Biopsy Software - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hologic Obtains CE Mark for Affirm\u00ae Contrast Biopsy Software - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Hologic Obtains CE Mark for Affirm\u00ae Contrast Biopsy Software Innovative Technology Allows Clinicians to Target and Acquire Tissue Samples Using Contrast-Enhanced Mammography MARLBOROUGH, Mass.&#8211;(BUSINESS WIRE)&#8211; Global women\u2019s health leader Hologic, Inc. (Nasdaq: HOLX) today announced that its Affirm\u00ae Contrast Biopsy Software, which combines contrast-enhanced diagnostic capabilities with accurate lesion targeting to help streamline workflow and accelerate biopsy procedures,1-2 is now CE-marked. The technology received clearance from the U.S. Food and Drug Administration in October 2020. Designed from the ground up to integrate with the Selenia\u00ae Dimensions\u00ae and 3Dimensions\u2122 systems, Hologic\u2019s Affirm Contrast Biopsy Software enables clinicians to target and acquire tissue samples in lesions identified through contrast-enhanced mammography (CEM). \u201cAt Hologic, we are committed to helping women live healthier lives &hellip; Continue reading &quot;Hologic Obtains CE Mark for Affirm\u00ae Contrast Biopsy Software&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-02-20T08:03:13+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250220676235r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\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:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Hologic Obtains CE Mark for Affirm\u00ae Contrast Biopsy Software\",\"datePublished\":\"2025-02-20T08:03:13+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\\\/\"},\"wordCount\":709,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20250220676235r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\\\/\",\"name\":\"Hologic Obtains CE Mark for Affirm\u00ae Contrast Biopsy Software - 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(Nasdaq: HOLX) today announced that its Affirm\u00ae Contrast Biopsy Software, which combines contrast-enhanced diagnostic capabilities with accurate lesion targeting to help streamline workflow and accelerate biopsy procedures,1-2 is now CE-marked. The technology received clearance from the U.S. Food and Drug Administration in October 2020. Designed from the ground up to integrate with the Selenia\u00ae Dimensions\u00ae and 3Dimensions\u2122 systems, Hologic\u2019s Affirm Contrast Biopsy Software enables clinicians to target and acquire tissue samples in lesions identified through contrast-enhanced mammography (CEM). \u201cAt Hologic, we are committed to helping women live healthier lives &hellip; Continue reading \"Hologic Obtains CE Mark for Affirm\u00ae Contrast Biopsy Software\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\/","og_site_name":"Market Newsdesk","article_published_time":"2025-02-20T08:03:13+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250220676235r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Hologic Obtains CE Mark for Affirm\u00ae Contrast Biopsy Software","datePublished":"2025-02-20T08:03:13+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\/"},"wordCount":709,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250220676235r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-obtains-ce-mark-for-affirm-contrast-biopsy-software\/","name":"Hologic Obtains CE Mark for Affirm\u00ae Contrast Biopsy Software - 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