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軟體每年用於評估600多萬美國患者的乳房密度
華盛頓州林伍德,2023年3月10日/美通社/--用於乳腺癌早期檢測的軟體的全球領先企業Volpara Health Technologies(“Volpara”、“Group”或“Company”;ASX:VHT)今天宣佈,美國食品和藥物管理局(FDA)敲定了一項新的美國聯盟法規,要求全國各地的乳房X光檢查設施告知患者他們的乳房是否由緻密組織組成。該規定規範了語言,並擴大了全國範圍內擁有密度披露法律的州的數量。
國家通報裁決
在接下來的18個月內-2024年9月10日-所有乳房X光檢查患者的報告和摘要必須包括以下關於乳房密度的文字,以告知患者其密度狀態為非密度或密度:
- 非緻密乳房通知稱:“乳房組織可能緻密,也可能不致密。緻密組織使乳房X光檢查更難發現乳腺癌,也增加了罹患乳腺癌的風險。您的乳房組織不致密。請向您的醫療保健提供者諮詢乳房密度、乳腺癌風險以及您的個人情況。”
- 緻密乳房通知稱:“乳房組織可以是緻密的,也可以是不致密的。緻密組織會增加乳房X光檢查發現乳腺癌的難度,也會增加罹患乳腺癌的風險。你的乳房組織是緻密的。在一些組織緻密的人中,除了乳房X光檢查外,其他成像測試可能有助於發現癌症。與你的醫療保健提供者談論乳房密度、乳腺癌風險以及你的個人情況。”
該裁決還規定了醫療保健提供者報告和摘要中關於乳房密度的語言是與BI-RADS相匹配的5這是版本密度類別。
FDA的乳房密度通知語言是公平賦予所有女性權力的關鍵一步美國瞭解他們的乳房密度,以便他們能夠採取知情的、可行的步驟來監測自己的乳房健康。泰瑞·託馬斯沃爾帕拉健康公司的首席執行官。
進一步提高精確度和能力的機會
在美國,每年進行近4000萬次乳房X光檢查,其中Volpara的軟體被用來評估每年超過600萬的乳房密度。
FDA的裁決承認密度分類設備的進步,以幫助減少評估中的可變性。
Volpara的支持醫生的體積乳房密度評估軟體長期以來在使準確、客觀的乳房密度評估成為可能方面發揮著越來越重要的作用。通過使用人工智慧(AI),Volpara提供了全面而精確的乳房密度測量,有助於確保更準確地評估乳腺癌風險。伏爾帕拉基於TruDensity物理的人工智慧算法通過了FDA、加拿大衛生部和TGA(澳大利亞),獲得CE認證,並已在400多篇文章和研究摘要中得到驗證。
託馬斯說:“十多年來,我們一直在與世界各地的領先臨床醫生和研究人員合作,使有關女性乳房成分及其與乳腺癌的聯繫的關鍵資訊更容易獲得。FDA的規定證實了我們的關注點,增加了業界對乳房密度的關注,並推動社會進步,改善患者和提供者的體驗和理解。“
Volpara的縮略圖模塊用患者乳房的兩張乳房X光圖像增強了患者乳房X光檢查結果,並用簡單易懂的術語解釋了乳房密度的含義。除了通知之外,這些新增功能還可以促進患者溝通,幫助提供者更多地幫助患者。Volpara用戶還可以使用工具,幫助他們進一步教育患者,介紹醫生和他們的社區。資訊性的小冊子、海報、教職員工劇本和其他教育輔助材料可以原樣使用,也可以由提供者定製。值得一提的是,Volpara創建了一個關於乳房密度的教育網站,其中包括一個遊戲化功能,可以可視化地展示緻密乳房中癌症是如何被掩蓋的。
此工具可在上查看。
關於乳房密度
緻密的乳房組織很常見,但已被認為與乳腺癌風險增加有關,也可能極大地影響早期發現。在……裡面美國在所有40歲以上的女性中,近一半的人乳房緻密。隨著密度的增加,乳房X光檢查的準確性會降低。根據發表在《紐約時報》的一項研究放射學在乳房最緻密的女性中,乳房X光檢查幾乎一半的乳腺癌患者沒有達到預期。由於緻密的乳腺組織和癌症在乳房X光照片上顯示為白色,因此腫瘤通常在乳房X光照片上被偽裝。研究證實,當乳房非常緻密的女性在常規篩查計劃中除了乳房X光檢查外,還接受超音波或核磁共振檢查,早期發現會有所改善。
Volpara Health Technologies開發了一款拯救家庭免受癌症侵襲的軟體。醫療保健提供者使用Volpara更好地瞭解癌症風險,增強患者的個人護理決策能力,並指導有關額外成像、基因測試和其他幹預措施的建議。我們的人工智慧圖像分析使放射科醫生能夠精確地量化乳房組織,並幫助技術人員製作具有最佳圖像質量、位置、壓縮和劑量的乳房X光照片。在一個面臨日益嚴重的人員短缺的行業中,我們的軟體建恩化了運營,並提供關鍵的績效洞察,支持持續的質量改進。
沃爾帕拉是全球領先醫療機構的首選合作夥伴。我們的軟體被5,000多名技術人員在2,000多家機構使用,影響了全球近1600萬名患者。它幫助提供商每年進行300多萬次癌症風險評估,可以獨立部署,也可以與電子健康記錄系統、乳房X光檢查報告系統、成像硬體和基因實驗室完全集成。Volpara擁有最嚴格的安全認證以及眾多專利和監管註冊,包括FDA許可和CE標誌。自2016年4月在澳交所上市以來,公司已籌集了1.32億澳元。有一間辦公室在西雅圖,Volpara總部設在紐西蘭惠靈頓.
有關更多資訊,請訪問。
來源:沃爾帕拉健康公司
譯文內容由第三人軟體翻譯。
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