EOS imaging, experts in 2D/3D orthopedic medical imaging, has just received approval from the China Food and Drug Administration (CFDA) to market the EOS system in China. The EOS system can now be marketed in 51 countries.
EOS imaging: Approval From China FDA
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As stated in the March 21, 2016 news release, “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, 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, Ph.D., 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.”
Dr. Meynadier told OTW, “Parallel to the strong and continued increase of our installed customer base, we are initiating deployment of our newest product, EOSapps. These cloud based services will allow surgeons to use our low dose 2D/3D images and patient anatomical datasets in planning and controlling their surgeries. Earlier this year we received CE mark for our spineEOS application for spine surgery planning and expect to launch it in the U.S. after receiving FDA authorization.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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