FDA Breast Density Reporting Rule Is a Critical Step for Women Says Volpara Health, the Leader in AI-assisted Breast Density Measurement
FDA Breast Density Reporting Rule Is a Critical Step for Women Says Volpara Health, the Leader in AI-assisted Breast Density Measurement
Volpara software is used to assess the breast density of more than 6 million US patients annually
LYNNWOOD, Wash., March 10, 2023 /PRNewswire/ -- Volpara Health Technologies ("Volpara," "the Group," or "the Company"; ASX:VHT), a global leader in software for the early detection of breast cancer, today announced that a new US federal regulation was finalized by the US Food and Drug Administration (FDA) requiring mammography facilities across the country to inform patients whether their breasts are composed of dense tissue. The regulation standardizes language and expands the number of states with density disclosure laws nationwide.
National Notification Ruling
Within the next 18 months—by 10 September 2024—all 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:
- Non-dense breast notification states: "Breast 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.
- Dense breast notification states: "Breast 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."
The ruling also specifies the language about breast density in reports and summaries for healthcare providers is to match the BI-RADS5th Edition density categories.
"The 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," said Teri Thomas, CEO of Volpara Health.
Opportunities for Further Accuracy & Empowerment
Nearly 40 million mammograms are performed each year in the US of which Volpara's software is used to assess the breast density of more than 6 million annually.
The FDA ruling acknowledges advancements in density classification devices to help mitigate variability in assessment.
Volpara's 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 VolparaTruDensity physics-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.
"We've been working with leading clinicians and researchers around the world for more than a decade to make critical information about women's breast composition and its link to breast cancer more readily available," said Thomas. "The FDA regulation validates our focus, increases the industry's attention on breast density, and propels society forward to improve both the patient and provider experience and understanding."
Volpara's Thumbnail module enhances patient mammography results letters with two mammogram images of the patient's 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. Volpara 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.
This tool can be viewed at .
About Breast Density
Dense breast tissue is common but has been linked to an increased risk for breast cancer and can also dramatically impact early detection. In the United States, nearly half of all women over 40 have dense breasts. As density increases, the accuracy of mammography decreases. According to a study published in Radiology, mammography misses almost half of breast cancers in 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 early detection improves when women with very dense breasts receive an ultrasound or MRI exam in addition to mammography as part of their regular screening schedule.
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.
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. Volpara holds the most rigorous security certifications and numerous patents and regulatory registrations, including FDA clearance and CE marking. Since listing on the ASX in April 2016, the Company has raised A$132 million. With an office in Seattle, Volpara is based in Wellington, New Zealand.
For more information, visit .
SOURCE Volpara Health, Inc.
Volpara软件每年用于评估600多万美国患者的乳房密度
华盛顿州林伍德,2023年3月10日/美通社/--用于乳腺癌早期检测的软件的全球领先企业Volpara Health Technologies(“Volpara”、“Group”或“Company”;ASX:VHT)今天宣布,美国食品和药物管理局(FDA)敲定了一项新的美国联邦法规,要求全国各地的乳房X光检查设施告知患者他们的乳房是否由致密组织组成。该规定规范了语言,并扩大了全国范围内拥有密度披露法律的州的数量。
国家通报裁决
在接下来的18个月内-2024年9月10日-所有乳房X光检查患者的报告和摘要必须包括以下关于乳房密度的文字,以告知患者其密度状态为非密度或密度:
- 非致密乳房通知称:“乳房组织可能致密,也可能不致密。致密组织使乳房X光检查更难发现乳腺癌,也增加了罹患乳腺癌的风险。您的乳房组织不致密。请向您的医疗保健提供者咨询乳房密度、乳腺癌风险以及您的个人情况。”
- 致密乳房通知称:“乳房组织可以是致密的,也可以是不致密的。致密组织会增加乳房X光检查发现乳腺癌的难度,也会增加罹患乳腺癌的风险。你的乳房组织是致密的。在一些组织致密的人中,除了乳房X光检查外,其他成像测试可能有助于发现癌症。与你的医疗保健提供者谈论乳房密度、乳腺癌风险以及你的个人情况。”
该裁决还规定了医疗保健提供者报告和摘要中关于乳房密度的语言是与BI-RADS相匹配的5.这是版本密度类别。
FDA的乳房密度通知语言是公平赋予所有女性权力的关键一步美国了解他们的乳房密度,以便他们能够采取知情的、可行的步骤来监测自己的乳房健康。泰瑞·托马斯沃尔帕拉健康公司的首席执行官。
进一步提高精确度和能力的机会
在美国,每年进行近4000万次乳房X光检查,其中Volpara的软件被用来评估每年超过600万的乳房密度。
FDA的裁决承认密度分类设备的进步,以帮助减少评估中的可变性。
Volpara的支持医生的体积乳房密度评估软件长期以来在使准确、客观的乳房密度评估成为可能方面发挥着越来越重要的作用。通过使用人工智能(AI),Volpara提供了全面而精确的乳房密度测量,有助于确保更准确地评估乳腺癌风险。伏尔帕拉基于TruDensity物理的人工智能算法通过了FDA、加拿大卫生部和TGA(澳大利亚),获得CE认证,并已在400多篇文章和研究摘要中得到验证。
托马斯说:“十多年来,我们一直在与世界各地的领先临床医生和研究人员合作,使有关女性乳房成分及其与乳腺癌的联系的关键信息更容易获得。FDA的规定证实了我们的关注点,增加了业界对乳房密度的关注,并推动社会进步,改善患者和提供者的体验和理解。“
Volpara的缩略图模块用患者乳房的两张乳房X光图像增强了患者乳房X光检查结果,并用简单易懂的术语解释了乳房密度的含义。除了通知之外,这些新增功能还可以促进患者沟通,帮助提供者更多地帮助患者。Volpara用户还可以使用工具,帮助他们进一步教育患者,介绍医生和他们的社区。资讯性的小册子、海报、教职员工剧本和其他教育辅助材料可以原样使用,也可以由提供者定制。值得一提的是,Volpara创建了一个关于乳房密度的教育网站,其中包括一个游戏化功能,可以可视化地展示致密乳房中癌症是如何被掩盖的。
此工具可在上查看。
关于乳房密度
致密的乳房组织很常见,但已被认为与乳腺癌风险增加有关,也可能极大地影响早期发现。在……里面美国在所有40岁以上的女性中,近一半的人乳房致密。随着密度的增加,乳房X光检查的准确性会降低。根据发表在《纽约时报》的一项研究放射学在乳房最致密的女性中,乳房X光检查几乎一半的乳腺癌患者没有达到预期。由于致密的乳腺组织和癌症在乳房X光照片上显示为白色,因此肿瘤通常在乳房X光照片上被伪装。研究证实,当乳房非常致密的女性在常规筛查计划中除了乳房X光检查外,还接受超声波或核磁共振检查,早期发现会有所改善。
Volpara Health Technologies开发了一款拯救家庭免受癌症侵袭的软件。医疗保健提供者使用Volpara更好地了解癌症风险,增强患者的个人护理决策能力,并指导有关额外成像、基因测试和其他干预措施的建议。我们的人工智能图像分析使放射科医生能够精确地量化乳房组织,并帮助技术人员制作具有最佳图像质量、位置、压缩和剂量的乳房X光照片。在一个面临日益严重的人员短缺的行业中,我们的软件简化了运营,并提供关键的绩效洞察,支持持续的质量改进。
沃尔帕拉是全球领先医疗机构的首选合作伙伴。我们的软件被5,000多名技术人员在2,000多家机构使用,影响了全球近1600万名患者。它帮助提供商每年进行300多万次癌症风险评估,可以独立部署,也可以与电子健康记录系统、乳房X光检查报告系统、成像硬件和基因实验室完全集成。Volpara拥有最严格的安全认证以及众多专利和监管注册,包括FDA许可和CE标志。自2016年4月在澳交所上市以来,公司已筹集了1.32亿澳元。有一间办公室在西雅图,Volpara总部设在新西兰惠灵顿。
有关更多信息,请访问。
来源:沃尔帕拉健康公司
译文内容由第三方软件翻译。
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