{"id":3878,"date":"2023-03-10T13:23:48","date_gmt":"2023-03-10T04:23:48","guid":{"rendered":"https:\/\/www.lunit.io\/?post_type=media-hub&#038;p=3878"},"modified":"2026-01-15T13:27:16","modified_gmt":"2026-01-15T04:27:16","slug":"fda-breast-density-reporting-rule-is-a-critical-step-for-women-says-volpara-health-the-leader-in-ai-assisted-breast-density-measurement","status":"publish","type":"media-hub","link":"https:\/\/www.lunit.io\/en\/media-hub\/fda-breast-density-reporting-rule-is-a-critical-step-for-women-says-volpara-health-the-leader-in-ai-assisted-breast-density-measurement\/","title":{"rendered":"FDA Breast Density Reporting Rule is a Critical Step for Women says Volpara Health, the Leader in AI-assisted Breast Density Measurement"},"content":{"rendered":"<h4><i><span data-contrast=\"none\">Volpara software is used to assess the breast density of more than 6 million US patients annually<\/span><\/i><\/h4>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"none\"><strong>Lynnwood, WA, March 10, 2023<\/strong>:\u00a0<\/span><a href=\"http:\/\/www.volparahealth.com\/\"><span data-contrast=\"none\">Volpara Health Technologies<\/span><\/a><span data-contrast=\"none\">\u00a0(\u201cVolpara,\u201d \u201cthe Group,\u201d or \u201cthe Company\u201d; ASX:VHT), a global leader in software for the early detection of breast cancer, today announced<\/span>\u00a0<span data-contrast=\"none\">that a\u00a0<\/span><a class=\"external-link\" href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-updates-mammography-regulations-require-reporting-breast-density-information-and-enhance\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">new US federal regulation<\/span><\/a><span data-contrast=\"none\">\u00a0was finalized by the US Food and Drug Administration (FDA)\u00a0<a href=\"https:\/\/www.volparahealth.com\/fda-density-notification\/\">requiring mammography facilities across the country to inform patients whether their breasts are composed of dense tissue<\/a>.\u00a0<\/span><a class=\"external-link\" href=\"https:\/\/public-inspection.federalregister.gov\/2023-04550.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">The regulation<\/span><\/a><span data-contrast=\"none\">\u00a0standardizes language and expands the number of states with density disclosure laws nationwide.<\/span><\/p>\n<p><b><span data-contrast=\"none\">National Notification Ruling<\/span><\/b><\/p>\n<p><span data-contrast=\"none\">Within the next 18 months\u2014by 10 September 2024\u2014all mammography patient reports and summaries must include the following language about breast density to inform the patient of their density status as either non-dense or dense:<\/span><\/p>\n<ul>\n<li><span data-contrast=\"none\">Non-dense breast notification states: \u201cBreast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.<\/span><\/li>\n<li><span data-contrast=\"none\">Dense breast notification states: \u201cBreast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.\u201d<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">The ruling also specifies the language about breast density in reports and summaries for healthcare providers is to match the BI-RADS<\/span><span data-contrast=\"none\"><sup>\u00ae<\/sup>\u00a0<\/span><span data-contrast=\"none\">5<\/span><span data-contrast=\"none\">th<\/span><span data-contrast=\"none\">\u00a0Edition density categories.<\/span><\/p>\n<p><span data-contrast=\"none\">\u201cThe FDA breast density notification language is a key step in equitably empowering all women in the United States to understand their breast density so they can take informed, actionable steps to monitor their own breast health,\u201d said Teri Thomas, CEO of Volpara Health.<\/span><\/p>\n<p><b><span data-contrast=\"none\">Opportunities for Further Accuracy &amp; Empowerment<\/span><\/b><\/p>\n<p><span data-contrast=\"none\">Nearly\u00a0<\/span><a class=\"external-link\" href=\"https:\/\/www.fda.gov\/radiation-emitting-products\/mqsa-insights\/mqsa-national-statistics\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">40 million mammograms are performed each year<\/span><\/a><span data-contrast=\"none\">\u00a0in the US of which Volpara\u2019s software is used to assess the breast density of more than 6 million annually.<\/span><\/p>\n<p><span data-contrast=\"none\">The FDA ruling acknowledges advancements in density classification devices to help mitigate variability in assessment.<\/span><\/p>\n<p><span data-contrast=\"none\">Volpara\u2019s volumetric breast density assessment software to support physicians has long played an increasingly important role in making accurate, objective assessments of breast density possible. Through the use of AI (artificial intelligence), Volpara provides a comprehensive and precise measurement of breast density that helps ensure breast cancer risk is more accurately assessed. The\u00a0<\/span><a href=\"https:\/\/www.volparahealth.com\/science\/algorithms\/density\/\"><span data-contrast=\"none\">Volpara<\/span><span data-contrast=\"none\"><sup>\u00ae<\/sup>\u00a0<\/span><span data-contrast=\"none\">TruDensity\u2122<\/span><\/a><span data-contrast=\"none\">\u00a0physics-based AI algorithm is cleared by the FDA, Health Canada, and the TGA (Australia), is CE-marked, and has been validated in more than 400 articles and research abstracts.<\/span><\/p>\n<p><span data-contrast=\"none\">\u201cWe\u2019ve been working with leading clinicians and researchers around the world for more than a decade to make critical information about women\u2019s breast composition and its link to breast cancer more readily available,\u201d said Thomas. \u201cThe FDA regulation validates our focus, increases the industry\u2019s attention on breast density, and propels society forward to improve both the patient and provider experience and understanding.\u201d<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-6801\" src=\"https:\/\/www.volparahealth.com\/app\/uploads\/2023\/03\/Thumbnail-graphic.png\" sizes=\"auto, (max-width: 138px) 100vw, 138px\" srcset=\"https:\/\/www.volparahealth.com\/app\/uploads\/2023\/03\/Thumbnail-graphic.png 267w, https:\/\/www.volparahealth.com\/app\/uploads\/2023\/03\/Thumbnail-graphic-99x300.png 99w\" alt=\"\" width=\"138\" height=\"419\" \/><\/span><\/p>\n<p><a href=\"https:\/\/www.volparahealth.com\/volpara-thumbnail-for-patients\/\"><span data-contrast=\"none\">Volpara\u2019s Thumbnail\u2122 module<\/span><\/a><span data-contrast=\"none\">\u00a0enhances patient mammography results letters with two mammogram images of the patient\u2019s breasts and explains the meaning of breast density in simple-to-understand terms. These additions beyond notification advance patient communication to help providers go the extra mile to help patients. \u00a0Volpara users also have access to tools which help them further educate patients, referring physicians and their community. Informative brochures, posters, staff scripts and other educational aids may be used as is or be customized by the provider. Of note, Volpara has created an educational website about breast density that includes a gamification feature to allow visualization of how cancer can be obscured in dense breasts.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">This tool can be viewed at\u00a0<\/span><a class=\"external-link\" href=\"http:\/\/www.volparadensity.com\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">www.volparadensity.com<\/span><\/a><span data-contrast=\"none\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"none\">About Breast Density<\/span><\/b><br \/>\n<span data-contrast=\"none\">Dense breast tissue is common but has been linked to\u00a0<\/span><a class=\"external-link\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5574657\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">an increased risk for breast cancer<\/span><\/a><span data-contrast=\"none\">\u00a0and can also dramatically impact early detection. In the United States, nearly half of all women over 40 have dense breasts. As density increases, the\u00a0<\/span><a class=\"external-link\" href=\"https:\/\/cebp.aacrjournals.org\/content\/15\/6\/1159.long\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">accuracy of mammography decreases<\/span><\/a><span data-contrast=\"none\">. According to a study published in\u00a0<\/span><i><span data-contrast=\"none\">Radiology<\/span><\/i><span data-contrast=\"none\">, mammography\u00a0<\/span><a class=\"external-link\" href=\"https:\/\/pubs.rsna.org\/doi\/abs\/10.1148\/radiol.2251011667\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">misses almost half of breast cancers<\/span><\/a><span data-contrast=\"none\">\u00a0in women with the densest breasts. Because dense breast tissue and cancer appear white on a mammogram, tumors are often camouflaged on a mammogram. Studies confirm that\u00a0<\/span><a class=\"external-link\" href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1903986\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">early detection improves<\/span><\/a><span data-contrast=\"none\">\u00a0when women with very dense breasts receive an ultrasound or MRI exam in addition to mammography as part of their regular screening schedule.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b><span data-contrast=\"none\">For further information, please contact:<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">MaryAnne Molter<\/span><br \/>\n<span data-contrast=\"none\">Senior Marketing Manager<\/span><br \/>\n<span data-contrast=\"none\">Volpara Health<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\"><br \/>\n<\/span><a class=\"external-link\" href=\"mailto:MaryAnne.Molter@VolparaHealth.com\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">MaryAnne.Molter@VolparaHealth.com<\/span><\/a><br \/>\n<span data-contrast=\"none\">414-339-9900<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"none\">About Volpara Health Technologies Limited (ASX:VHT)<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Volpara Health Technologies makes software to save families from cancer. Healthcare providers use Volpara to better understand cancer risk, empower patients in personal care decisions, and guide recommendations about additional imaging, genetic testing, and other interventions. Our AI-powered image analysis enables radiologists to quantify breast tissue with precision and helps technologists produce mammograms with optimal image quality, positioning, compression, and dose. In an industry facing increasing staffing shortages, our software streamlines operations and provides key performance insights that support continuous quality improvement.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Volpara is the preferred partner of leading healthcare institutions around the world. Our software is used in over 2,000 facilities by more than 5,000 technologists, impacting nearly 16 million patients globally. It helps providers conduct more than three million cancer risk assessments each year and can be deployed stand-alone or fully integrated with electronic health record systems, mammography reporting systems, imaging hardware, and genetic laboratories.\u202fVolpara\u202fholds the\u202fmost rigorous security certifications\u202fand\u202fnumerous patents and regulatory registrations, including FDA clearance and CE marking. Since listing on the ASX in April 2016,\u202fthe Company\u202fhas raised A$132 million. With an office in Seattle, Volpara is based in Wellington, New Zealand.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">For more information, visit\u00a0<\/span><a href=\"http:\/\/www.volparahealth.com\/\"><span data-contrast=\"none\">www.volparahealth.com<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n","protected":false},"author":8,"featured_media":3879,"parent":0,"template":"","media-hub-type":[36],"class_list":["post-3878","media-hub","type-media-hub","status-publish","has-post-thumbnail","hentry","media-hub-type-cancer-screening"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Breast Density Reporting Rule is a Critical Step for Women says Volpara Health, the Leader in AI-assisted Breast Density Measurement - 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