FDA Approves Stand-alone 3D Screening With Siemens Tomosynthesis Platform

Siemens Healthineers has announced that the Food and Drug Administration (FDA) has approved the use of 3D-only screening mammography utilizing the company’s Mammomat Inspiration with Tomosynthesis Option digital mammography system. The Siemens system is the first and only 3D digital breast tomosynthesis (DBT) platform to be approved by the FDA as a stand-alone screening and diagnostic system; all other mammography systems on the market require a combination of 2D and 3D examinations.

FDA approval of the 3D-only application follows a pivotal reader study in which participating radiologists demonstrated their ability to increase cancer detection at a lower radiation dose than combined 2D and DBT. In the study, radiologists decreased average recall rates by an average of 19 percent without the need for a 2D image.

“Siemens is proud to announce the availability of 3D-only screening with our Mammomat Inspiration with Tomosynthesis Option digital mammography system,” said Martin Silverman, Vice President of X-ray Products at Siemens Healthineers. “Although this is the first breast tomosynthesis solution on the market to demonstrate statistically superior results to 2D as a stand-alone breast exam, we know many providers will continue using 3D tomosynthesis as an adjunct to 2D screenings. Those providers who use our platform, however, will do so with confidence, knowing our 3D is a proven stand-alone option.”

Siemens’ Tomosynthesis Only Option is available on the company’s Mammomat Inspiration and Mammomat Inspiration Prime Edition digital mammography systems.

EOS imaging Received CFDA Approval for the EOS System

EOS imaging announced that the Company has received approval from the China Food and Drug Administration (CFDA) to market the EOS system in China, further expanding the Company’s commercial opportunities in the fast growing Asia Pacific market. The EOS system can now be marketed in 51 countries.

The EOS system is in clinical use in several markets in the Asia Pacific region, including Hong Kong, Singapore, Japan, Australia and Vietnam. In addition, an EOS equipment is installed in a Shanghai hospital where it is being used for clinical studies, creating awareness for the EOS technology in China. The CFDA approval will allow the company to develop commercial activity in this major market, which includes more than 1,200 top grade (3A and 3B) hospitals, within an established distribution partnership.

Experience with the EOS system will be shared with Chinese physicians by several French radiologists and orthopedic surgeons during the upcoming Jishuitan Orthopedics Forum in Beijing, April 22-24, 2016. The Forum is a biennial, multi-disciplinary event focused on orthopedics that attracts more than 3,000 attendees from over 1,200 hospitals. This year, the Forum includes special sessions for Chinese-French exchange across multiple areas of orthopedic treatment, including spine, joint articulation, pediatrics and radiology.

Marie Meynadier, CEO of EOS imaging, said, “CFDA approval is an important milestone that opens a large and growing market opportunity for our Company. It is consistent with our strategy to expand adoption of the EOS system in 3 major regions – North America, Europe-Middle East and Asia-Pacific – to diversify our revenue growth and long-term potential. We are excited to begin commercial activities in China with our local partner, where there is already positive awareness and demand for the EOS system.”

For more information, please visit www.eos-imaging.com.

Opportunities for cancer diagnostics and treatment devices

It is believed that many patients suffering from cancer could be treated if the tumor can be detected at very early stage.


Number of newly diagnosed cancer patients in China

As per statistics, number of newly diagnosed cancer patients keeps growing in China, which escalates the demand of medical devices and in-vitro products such as early screening devices, diagnostic devices, bio-markers, imaging devices and radiology equipment. This also generates opportunities for medical examination centers as well as independent medical imaging centers.