A new standard for automated breast density assessment. The quantra software uses an algorithm that can provide four categories of density assessments to clinicians performing routine breast cancer screenings. This in fact can increase the us populations access to the same level of care, as most of the mammograms are not read by radiologists specifically trained to interpret breast density. Description hologic qdr 4500 dexa, fan beam, hip and spine, good entry level bone density system. Jan 05, 2015 two software packages were used to assess the breast density on each mammogram quantra version 2. Hologic selected for dutch breast cancer screening program. Our cuttingedge technologies are grounded in scientific precision and clinical accuracy to make earlier detection and treatment possible for more patients. Hologics 3dimensions mammography system now available in. Hologic s r2 quantra volumetric breast density assessment tool is a software application for use with hologic digital mammography systems as an automated method for assessing breast density. Nov 26, 2017 fda clears hologic s breast density assessment software by staff writers.
This is critical for women with dense breasts, because higher breast density is known to increase a womans risk for breast cancer. This one hour workshop will give a short overview of current literature on mammography breast density followed by an interactive hands on session. As awareness of breast density as a risk factor for cancer grows, so does the need for accurate, more consistent analysis. Food and drug administration fda for its quantra 2. Find out more about our comprehensive portfolio of breast and skeletal health solutions including new innovations at ecr2020 in vienna.
Hologic is the world leader in breast cancer screening and the pioneer behind the genius 3d mammography exam, first approved by the fda in 2011 on the companys firstofitskind 3d. From hologic 3d mammography, proven to detect breast cancer at an earlier stage, to unprecedented advances in bone health, hologic imaging solutions break through technological limitations to provide greater. Hologics r2 quantra automates breast density assessment. It creates an internal 3d model of the breast from which it derives estimates of the fibroglandular tissue volume and total breast volume. Hologic wins fda clearance for breast density software 2017. Under the tender, stateoftheart 3dimensionstm mammography systems will be installed starting in 2018.
Quantra breast density assessment software is one of the several new products that are being demonstrated at hologics booth at the 103rd scientific assembly and annual meeting of. The appropriate cutoff for breast densitybased risk stratification using quantra software was calculated using manually determined birads. High breast density has also been linked to cancers which are larger and have positive lymph nodes, although the reported results vary considerably,, and high breast density has been found in women with cancers diagnosed outside of the screening programme. The nextgeneration quantra breast density assessment software enables quick and accurate breast density assessments across your entire patient population, elevating the standard of care and. Today, hologic has installed more than 5,000 3d mammography systems throughout the united. As part of our commitment to womens health, we are dedicated to support you across the breast health continuum of care. The new product is the latest addition to hologics portfolio of marketleading breast cancer screening, diagnostic and interventional solutions. Fda approves new innovations on hologics 3dimensions. This software helps clinicians provide women with consistent breast density. Breast density, or fibroglandular density, is found through breast imaging and compares. Powerlook density assessment is an automated breast density solution that is designed to standardize the assessment of breast density in 2d and 3d mammography. The cases will have tomosynthesis, 2d and synthesized 2d as well as results from an automatic scoring. The r2 quantra hologic software is a volumetric computerized breast density tool developed for this purpose. The software helps radiologists and clinicians to provide information about breast density to women during routine breast cancer screenings.
Fda clears hologics breast density assessment software. Holx free report announced the receipt of fda 510k clearance for its quantra 2. Assure proper functioning of hardwaresoftware and request service from hologic. Hologic qdr 4500 community, manuals and specifications.
Women with dense breast tissue are at higher risk for developing breast cancer. Quantra breast density assessment software is a machinelearning algorithm that analyzes each patients pattern and texture. Holx announced today that it has received 510k clearance from the united states food and drug administration fda for its quantratm 2. Whole body and hip dxa bone density most operations manual page 4 whole body and hip dxa bone density version 1. Comparing visually assessed birads breast density and. That information then is automatically included in the report and, if dense breast tissue is detected, the system generates the proper letter to be sent to the patient. The r2 quantra volumetric assessment software version 1. Nov 28, 2017 quantra breast density assessment software is one of the several new products that are being demonstrated at hologics booth at the 103rd scientific assembly and annual meeting of the rsna. Potential advantages include having not only a reliable and highly reproducible calculation but also increased speed of determining a breast density and increased efficiency of reporting it. Hologic is the world leader in breast cancer screening and the pioneer behind the genius 3d mammography exam, first approved by the fda in 2011 on the companys firstofitskind 3d mammography system. The software enables clinicians to provide women with consistent breast density assessments during routine breast cancer screenings. Powerlook density assessment assists radiologists in evaluating and scoring breast density to identify patients who may need supplemental screening or be at higher risk of developing breast cancer.
Two software packages were used to assess the breast density on each mammogram quantra version 2. Clinical considerations in implementing breast tomosynthesis. Holx announced today that it has received 510k clearance from the united states food and drug administration fda for. This is the latest in the firms breast cancer screening. Evaluation of quantra hologic volumetric computerized. Download a breast density annotated bibliography here. Holx announced today that it has received 510k clearance from the united states food and drug administration fda for its quantra 2. The nextgeneration quantra breast density assessment software enables quick and accurate breast density assessments across your entire patient population, elevating the standard of care and standardizing reporting. Hologics fda nod for quantra software boosts breast health.
November 26, 2017 womens imaging firm hologic has received u. From the makers of the only mammogram proven superior for dense breasts compared to 2d alone. Now hologic tomosynthesis benefits are available in a lower dose, faster and more comfortable exam. Viera breast performance software with clarius hd hologic. The nextgeneration quantra breast density assessment software enables fast, consistent breast density assessment across your entire patient population. The 4500 is the perfect solution for a physician that wants to get into fan beam technology and is on a limited budget, or is looking for an upgrade from a pencil beam. From hologic 3d mammography, proven to detect breast cancer at an earlier stage, to unprecedented advances in bone health, hologic imaging solutions break through. Fda clears hologics breast density assessment software by staff writers. Clinicians across europe have made clear their desire for breast cancer screening technology that offers improved accuracy, clarity and workflow, and the 3dimensions system addresses each of those specific areas, hologics jan verstreken, regional president for emea and canada, pointed out during the launch of the new system.
Quantra breast density assessment software is a machinelearning algorithm that analyzes each patients pattern and texture to provide an unbiased breast density assessment. Holx announced the receipt of fda 510k clearance for its quantra 2. The output from each program consisted of values for the absolute volume of fibroglandular tissue and overall breast volume, as well as the volumetric breast density on a per. Evaluation of quantra hologic volumetric computerized breast. Our portfolio of lifesaving and lifeenhancing products encompasses breast and skeletal solutions, gyn surgical solutions, and diagnostic solutions. Hologic low dose 3d mammography exam with cview software.
One possible explanation for the latter is a masking bias, in that dense. This software helps clinicians provide women with consistent. Hologics r2 quantra volumetric breast density assessment tool is a software application for use with hologic digital mammography systems as an automated method for assessing breast density. Whole body and hip dxa bone density most operations. Hologic receives fda 510k clearance of quantratm 2. At hologic, we apply cuttingedge science to accelerate discovery, improve efficiency and continually sharpen precision. Women with dense breasts have a higher risk of breast cancer because dense tissue can obscure lesions on a traditional mammogram.
At hologic, enhancing early detection, improving diagnostic accuracy and delivering compassionate technologies continually drive the development of our imaging solutions. Streamlined workflow exclusive applications for diagnostic breast and interventional breast with dense breast, needle and marker enhancement modes customizable breast annotations and breast reporting package. Quantra breast density assessment software provides an objective method of assessing a patients breast density. Evaluation of quantra hologic volumetric computerized breast density software in comparison with manual interpretation in a diverse population.
Food and drug administration fda 510k clearance for its quantra 2. Hologic holx granted fda 510k clearance of quantra 2. For women facing breast cancer, hologic is there from screening. Nov 02, 2017 under the tender, stateoftheart 3dimensionstm mammography systems will be installed starting in 2018. For example, by teaming with volpara and hologics quantra volumetric assessment software, mrs provides automated information regarding a patients breast density status. Blog exposure hologic gets fda clearance for quantratm 2. It also announced the receipt of the 510k clearances from the fda for its quantra 2. Mammographic density and breast cancer risk in breast. Standardized breast density assessments women with dense breasts have a higher risk of breast cancer because dense tissue can obscure lesions on a traditional mammogram.
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