U-Systems Introduces Significant Upgrades to 3D Automated Breast Ultrasound Workstation at RSNA

CHICAGO, Nov 29, 2010 (BUSINESS WIRE) -- U-Systems, Inc., the leader in automated breast ultrasound, announced significant upgrades for its somo*v(R) Automated Breast Ultrasound System (ABUS) at the 96th Annual Meeting of the Radiology Society of North America, November 28 -- December 3. Featuring software improvements and hardware-accelerated programming, Release One*5 and SomoSTORAGE(TM) Departmental Storage Solution upgrades are designed to enable faster access to patient images and help radiologists simplify reading protocols for higher productivity.

Release One*5 is the latest update to U-Systems somo*VIEWer(TM) Advanced ABUS Workstation. It supports import/export of all DICOM images and Compare View allows side-by-side comparison of same-patient serial exams. Active-Motion Transition maintains view acuity during layout transitions for reduced read times. Release One*5 also establishes a bi-directional e-link to Hologic SecurView(TM) diagnostic workstations, allowing corresponding mammography and ABUS cases to be opened simultaneously.

U-Systems also announced the introduction of SomoSTORAGE(TM) Departmental Storage Solution, designed to store multimodality breast images, including large-volume 3D ultrasound data files. SomoSTORAGE delivers a new way to view data storage directories, transforming ordinary, text-based file names into graphic-based image galleries for rapid visualization of the file content. This offers additional value for quick consolidation of teaching cases and training databases.

source: Business Wire

Hologic Receives FDA Approvable Letter For Selenia Dimensions (3-D) Digital Mammography Tomosynthesis System

BEDFORD, Mass., (November 23, 2010) - Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today that Hologic has received an approvable letter from the U.S. Food and Drug Administration (FDA) for the Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system. Final approval of the Company's pre-market approval application for the system remains subject to satisfactory review and inspection of our manufacturing facility, methods and controls. The Company plans to work closely with the FDA to complete this final inspection.

"We are extremely pleased to have received the FDA's approvable letter, which represents an important step forward in the commercialization of our Selenia Dimensions tomosynthesis system," said Rob Cascella, President and Chief Executive Officer. "The Selenia Dimensions technology is designed to provide radiologists with enhanced screening and diagnostic capabilities through the incorporation of fast, high-quality 3-D imaging in combination with 2-D imaging. We believe this new technology will address many of the limitations present in stand-alone 2-D imaging and improve upon both sensitivity and specificity. We look forward to working with the FDA to complete the remaining steps in the approval process."

source: Hologic

Siemens MAMMOMAT Inspiration Digital Mammography Commercially Available in U.S.

Malvern, Pa., November 17, 2010 – Siemens announces that the MAMMOMAT® Inspiration Full-Field Digital Mammography System is now commercially available in the United States. The MAMMOMAT Inspiration offers digital screening and diagnostic mammography, stereotactic biopsy, and upgrade capability to future technologies all in one system.

Siemens conducted customer workshops around the world, in which radiologists, radiology technologists and physicists contributed details and suggestions on their vision for a next generation digital mammography system.

“The MAMMOMAT Inspiration is a direct result of that customer feedback so it was truly inspired by them,” said Gerhard Schmiedel, vice president, X-ray Products, Siemens Healthcare. “The system was designed to help provide a more pleasant examination environment for patients, more efficient workflow for technologists, and excellent image quality for physicians.”

source: Siemens Medical

Radiology Journal Publishes Data That PEM Scanners May Reduce Unnecessary Breast Biopsies And Offer An Alternative For Women Who Cannot Tolerate MRI

The Radiology journal released new data from an NIH-sponsored, multi-site study of hundreds of women with newly diagnosed breast cancer that shows Positron Emission Mammography (PEM) may reduce unnecessary breast biopsies. The study found that PEM was significantly more precise at identifying benign and cancerous lesions, in what scientists call "Positive Predictive Value" or "PPV," therefore reducing the number of unnecessary biopsies. A common physician complaint regarding the use of Breast MRI is its tendency to identify suspicious lesions, requiring biopsies, which ultimately are found to be benign.

This finding is a welcomed outcome for women and physicians looking for ways to reduce the patient trauma associated with biopsies and for payors looking to reduce the costs associated with unnecessary procedures. The 388 woman study showed that PEM not only demonstrated a six percent improvement in specificity at comparably high sensitivity, but that PEM also had 31 fewer unnecessary biopsies and 26% higher PPV than Breast MR.

source: Naviscan

FDA Reclassifies Certain Digital Mammography Devices

The U.S. Food and Drug Administration announced that it is easing the pathway to market for mammography systems that produce computerized X-ray images of the entire breast.

These systems, known as Full Field Digital Mammography Systems, are an alternative to mammography systems that produce X-ray film.

When first approved by FDA in 2000, digital mammography systems were categorized as a high risk or Class III device, because they were then considered novel systems for screening and diagnosing breast cancer.

Since then, digital mammography has been well-validated in scientific studies involving tens of thousands of patients. The benefits and risks of digital versus film mammography have also been well -described to physicians. As a result, the FDA has decided to reclassify digital mammography from Class III devices to Class II or medium risk devices.

source: Medical News Today