Technology | February 11, 2011

Hologic Receives FDA Approval for Breast Tomosynthesis System

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

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