News | Breast Imaging | January 18, 2016

Saudi Food and Drug Authority Approves LumaGEM Molecular Breast Imaging Solution

Women throughout the Middle East will now have access to new technology for early breast cancer detection

Gamma Medica, LumaGEM, molecular breast imaging, Kingdom of Saudi Arabia, KSA approval

January 18, 2016 — Gamma Medica Inc. announced the Saudi Food and Drug Authority (SFDA) has issued a Medical Device Marketing Authorization (MDMA) for their LumaGEM breast imaging product. This MDMA allows Gamma Medica to market the LumaGEM using molecular breast imaging (MBI) technology in the Kingdom of Saudi Arabia (KSA). Integrated Business Ventures Co. Ltd. (IBV) based in Riyadh, Saudi Arabia, is Gamma Medica's authorized representative and strategic partner for the KSA and the Middle East markets.

According to the National Cancer Registry and leading cancer care centers, there are an estimated 8,000 to 12,000 new cases of breast cancer discovered each year in KSA. It has been reported that up to 60 percent of these cases are diagnosed at later symptomatic stages, which significantly reduces the five-year survival rate from over 90 percent at an early detection stage to about 22 percent in later symptomatic stages. According to the King Faisal Specialist Hospital and Research Center in Riyadh, breast cancer represents 24 percent of all cancer cases, making it the most common form of cancer in women in KSA. Coupled with the extreme shortages of radiologists, LumaGEM will likely reduce the clinical burden and enable more women to be screened.

Dense breast tissue makes it more difficult to detect cancer, as lesions can be masked on standard X-ray mammogram that uses anatomical imaging as a way of detection. MBI is a functional imaging modality that highlights metabolic activity in breast tumors not visible on mammography due to tissue density, thereby leading to earlier diagnosis, improved outcomes and lowered costs. Recently published studies have shown that the addition of MBI for women with dense breast tissue results in an estimated 4 times increase in breast cancer detection rates, 50 percent reduction in biopsies and a subsequent 15 percent lower cost per cancer detected than screening with mammography alone. Moreover, the MBI procedure is very well tolerated by patients due to the reduced tissue compression on the breast during the examination.

It is important for women to discuss with their doctors if MBI is an appropriate screening modality for them. The MBI technology is an appropriate choice for all early detection and diagnosis of breast cancer In addition to women with dense breast tissue or suspicious lesions, MBI is also appropriate for high-risk patients with a family history of breast cancer, patients who have tested positive for BRCA1 or BRCA2 genes, symptomatic patients, patients with cosmetic augmentation or patients who cannot undergo a magnetic resonance imaging (MRI) investigation.

For more information: www.gammamedica.com

Related Content

Fujifilm Announces Nationwide Breast Health Campaign With Mobile Mammography Coach

At the center of the campaign, Fujifilm will be traveling around the U.S. with its "Aspire to Be Fearless" mobile mammography coach to provide educational opportunities for clinicians, raise awareness about the importance of screening and will be providing mammograms to the underserved population in key locations.

News | Mammography | June 14, 2019
Fujifilm Medical Systems U.S.A. Inc. announced a nationwide awareness campaign titled ‘Aspire to Be Fearless’ focused...
Ikonopedia Showcases Risk Assessment and Resolution Manager Tools at SIIM and AHRA
News | Mammography Reporting Software | June 13, 2019
Ikonopedia will showcase its suite of structured breast reporting and Mammography Quality Standards Act (MQSA)...
Sponsored Content | Videos | Radiology Imaging | June 13, 2019
In an interview with itnTV, Henry Izawa, vice president, modality solutions and clinical affairs, Fujifilm Medical Sy
iCAD Introduces ProFound AI for 2D Mammography in Europe
News | Artificial Intelligence | June 13, 2019
iCAD Inc. announced the launch of ProFound AI for 2D Mammography in Europe. This software is the latest addition to...
Three Palm Software Releases WorkstationOne Version 1.8.8
Technology | Mammography Reporting Software | June 12, 2019
Three Palm Software announced the release of the 1.8.8 version of its breast imaging workstation, WorkstationOne. This...
A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse

Figure 1. A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse from Amsterdam Ph.D. researcher Gustav Strijkers.

News | Magnetic Resonance Imaging (MRI) | June 07, 2019
The Amsterdam University Medical Center has won MR Solutions’ Image of the Year 2019 award for the best molecular...
BGN Technologies Introduces Novel Medical Imaging Radioisotope Production Method
News | Radiopharmaceuticals and Tracers | June 05, 2019
BGN Technologies, the technology transfer company of Ben-Gurion University (BGU), introduced a novel method for...
Volpara Health Technologies to Acquire MRS Systems Inc.
News | Mammography Reporting Software | June 04, 2019
Volpara Health Technologies, Volpara Solutions' parent company, has signed a binding agreement to acquire U.S.-based...
62-year-old female patient presenting for 3D screening mammogram. Location of an indeterminate low-density circumscribed mass was not clearly determined as at the skin line or just under the surface.

62-year-old female patient presenting for 3D screening mammogram. Location of an indeterminate low-density circumscribed mass was not clearly determined as at the skin line or just under the surface.

Feature | Mammography | May 31, 2019 | By Olive Peart M.S., R.T.(R)(M)
In recent years there has been a lot of debate about the role of the...
Quantitative Transmission Ultrasound Featured at Acoustical Society of America

Fused QT Ultrasound 3-D quantitative transmission ultrasound and compounded reflection axial images showing high resolution image of internal organs, tissue, skin and hair of neo-natal piglet. Anatomy courtesy of C. Ruoff, DVM.

News | Ultrasound Imaging | May 29, 2019
May 29, 2019 — QT Ultrasound recently showcased its advanced...