Technology | Breast Density | January 31, 2019

Recent FDA clearance enhances breast density assessment performance and expands types of information provided to clinicians

 Volpara Solutions Launches Next-Generation VolparaDensity Software to Support SmartCurve Paddles

January 31, 2019 — Volpara Solutions Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for new technologies used in the Volpara Density clinical application for breast density assessment. The updated version of VolparaDensity more accurately reflects breast density from images captured using the Hologic SmartCurve system.

This VolparaDensity update also supports additional breast imaging systems, such as the Siemens Mammomat Fusion and Mammomat Revelation® systems.

As one of the clinical applications within Volpara Enterprise software, VolparaDensity provides radiologists with automated, objective volumetric breast density assessments and a breast density category shown to correlate to the Breast Imaging-Reporting and Data System (BI-RADS) 4th and 5th Editions. It is CE-marked and cleared by the FDA, Health Canada and the TGA.

Women with dense breasts not only have an increased risk of breast cancer but are also impacted by lower mammographic sensitivity that dramatically reduces the chances of early detection. Several large studies have confirmed that as density increases the accuracy of mammography decreases. Thus, women with dense breasts are candidates for additional screening with either ultrasound or magnetic resonance imaging (MRI) depending on their breast density and risk profile.

For more information: www.volparasolutions.com

Related Content

News | Mammography

October 19, 2021 — If Black women begin mammography screening every other year starting at age 40, breast cancer deaths ...

Time October 19, 2021
arrow
News | Artificial Intelligence

October 19, 2021 — South Korean artificial intelligence (AI) developer, VUNO Inc., announced that the company closed a ...

Time October 19, 2021
arrow
News | Radiographic Fluoroscopy (RF)

October 18, 2021 — Long Island Jewish Valley Stream of Valley Stream, N.Y., recently became the first healthcare ...

Time October 18, 2021
arrow
News | Ultrasound Imaging

October 15, 2021 — NeuroLogica Corp., the U.S. healthcare subsidiary of Samsung, introduces the V8; a high-end ...

Time October 15, 2021
arrow
News | Ultrasound Women's Health

October 14, 2021 — In a first-in-world clinical trial, researchers at Sunnybrook Health Sciences Centre in Toronto ...

Time October 14, 2021
arrow
News | Breast Imaging

October 14, 2021 — Delphinus Medical Technologies, Inc. announced that the U.S. Food and Drug Administration (FDA) has ...

Time October 14, 2021
arrow
News | Women's Health

October 11, 2021 — Electrical engineering professor Magda El-Shenawee’s effort to develop a more accurate and less ...

Time October 11, 2021
arrow
News | Women's Health

October 8, 2021 — An analysis of nearly 200,000 patients who received mammograms between 2006 and 2015 across three U.S ...

Time October 08, 2021
arrow
News | Enterprise Imaging

October 8, 2021 — HealthLevel, Inc., innovator of Foundations, a business operations analytics platform for healthcare ...

Time October 08, 2021
arrow
News | MRI Breast

October 7, 2021 — An automated system that uses artificial intelligence (AI) can quickly and accurately sift through ...

Time October 07, 2021
arrow
Subscribe Now