FDAnews Device Daily Bulletin

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.

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

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.

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.

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.

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.

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.

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