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Fdanewsdevicedailybulletin

Oct. 31, 2012

Vol. 9 No. 214

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Radiology Panel Gives Thumbs Up to New 3-D Mammography Use

The FDA’s Radiological Devices Advisory Panel voted Wednesday to support expanded indications for the Hologic Selenia Dimensions C-View Software Module when used with the Selenia 3-D mammography device. Read More

U.S. Device Groups Seek Harmony With China

AdvaMed and the Medical Imaging & Technology Alliance (MITA) joined forces in Beijing late last month to improve harmonization with China. Read More

J&J Recalls Surgical Stapler Devices Over Serious Safety Issue

Johnson & Johnson has recalled more than 157,000 surgical stapler devices and accessories used in hemorrhoids treatment procedures due to potential malfunctions that pose a serious safety risk. Read More

The Future of Orthopedics: Match the Right Patients & Treatments

From a financial perspective, the market for orthopedic devices, procedures and tools has maintained steady growth over the last decade and is expected to see modest, single-digit growth over the next several years. Read More

Medical Implants Receive little Oversight in Europe and U.S.

A joint investigation released last week by the Daily Telegraph and the British Medical Journal showed poor oversight by European Union agencies responsible for certifying the safety of new medical implants. Read More

A Big FDA Day for Med-Tech Startup CoAxia

Medical-device startup CoAxia’s technology will go before an FDA advisory panel for a review that will be critical to the company's future. Read More

Stanford, Prenatal Blood Test Company Say Rival Infringes Patent

Stanford University’s board of trustees and Verinata Health Inc. sued prenatal blood test maker Ariosa Diagnostics in California federal court Wednesday, alleging the company’s Harmony prenatal test for Down syndrome and other fetal chromosomal disorders infringes a Stanford patent. Read More

Annapolis Medical Device Maker Partners With Boston Hospital on Patient Monitoring

Annapolis medical device company Zephyr Technology is collaborating with Massachusetts General Hospital on its OmniSense system for monitoring patients' vital signs. Read More