February 11, 2011 — Hologic Inc. today announced the company received approval from the U.S. Food and Drug Administration (FDA) for its Selenia Dimensions digital breast tomosynthesis system (Dimensions 3-D).

Mammography systems using conventional 2-D imaging have limitations caused by tissue overlapping tissue in the breast that may hide lesions or cause benign areas to appear suspicious. Clinical trials using Hologic's Dimensions 3-D system showed measurable improvement in clinical performance over conventional mammography. These trials also showed significant gains in specificity — the confidence to rule out cancer without recalling the patient for further study — and other benefits, including improved lesion and margin visibility and the ability to accurately localize structures in the breast.

"We are extremely proud to be the first company to receive FDA approval of a 3-D digital mammography system and to offer women this ground-breaking, superior imaging technology," said Rob Cascella, president and CEO. "We believe tomosynthesis has the potential to change how screening and diagnostic mammography is performed, and over time will prove invaluable to the earliest possible detection of breast cancer and in the reduction of unnecessary diagnostic interventions."

Hologic's Dimensions 3-D system is available commercially in more than 40 countries, including countries in Europe, Latin America and Asia. In North America, commercial systems are already installed in Canada and Mexico.

The Dimensions 3-D mammography system is a new method for breast cancer screening and diagnosis. Breast tomosynthesis produces 3-D images which are intended to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density. Tomosynthesis images are acquired with the breast held briefly in compression. The examination, which includes a 3-D tomosynthesis image in combination with a 2-D image, takes only seconds longer than a conventional 2-D digital mammogram at a total exam dose within current FDA guidelines. The 3-D scan results in a stack of thin, high-resolution image slices intended to provide clear rendition of structures in the breast and their spatial relationship with the surrounding breast tissue. The images are displayed on a standard diagnostic workstation for review by the radiologist.

Dimensions 3-D software is a purchasable option on existing Selenia Dimensions 2-D systems. Enabling the 3-D capability on a Dimensions 2-D system involves a software key and adjusting a PC-board setting. There is no need for new hardware.

For more information, visit www.hologic.com


Related Content

News | Computed Tomography (CT)

SPONSORED CONTENT — Fujifilm’s latest CT technology brings exceptional image quality to a compact and user- and patient ...

Time August 06, 2024
arrow
News | Radiology Business

July 31, 2024 — The American Registry of Radiologic Technologists (ARRT) announced the three Registered Technologists (R ...

Time July 31, 2024
arrow
Feature | Computed Tomography (CT) | By Melinda Taschetta-Millane

In the ever-evolving landscape of medical imaging, computed tomography (CT) stands out as a cornerstone technology ...

Time July 30, 2024
arrow
Videos | Radiology Business

Find actionable insights to achieve sustainability and savings in radiology in this newest of ITN’s “One on One” video ...

Time July 30, 2024
arrow
News | Breast Imaging

July 29, 2024 — Lunit, a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, announced the ...

Time July 29, 2024
arrow
News | Breast Imaging

July 29, 2024 — iCAD, Inc., a global leader in clinically proven AI-powered cancer detection solutions, announced a ...

Time July 29, 2024
arrow
Feature | Radiology Business | By Christine Book

Across the healthcare industry, and, notably, throughout the radiology community in just the past few years, the focus ...

Time July 26, 2024
arrow
Feature | Mobile C-Arms | By Melinda Taschetta-Millane

Mobile C-arms continue to revolutionize medical imaging, offering versatility, mobility and real-time visualization ...

Time July 26, 2024
arrow
News | Radiology Business

July 25, 2024 — Immunis, Inc., a clinical-stage biotech developing groundbreaking secretome therapeutics for age and ...

Time July 25, 2024
arrow
News | Radiology Business

July 25, 2024 — The radiology gender gap is decreasing, but there remains work to be done, according to an editorial ...

Time July 25, 2024
arrow
Subscribe Now