The FDA has released two new draft guidance documents aimed at establishing earlier clinical studies during device development while also clarifying the agencys process for approving clinical trials.

Sectra (Booth 9117) is unveiling PACS support for breast tomosynthesis images at the 97th Annual Meeting & Scientific Assembly of the RSNA, Nov. 27 to Dec. 2 in Chicago.

The FDA has sent a warning letter to International Isotopes, a radiochemical product manufacturer based in Idaho Falls, Idaho, due to violations of Current Good Manufacturing Practice regulations.

The evaluation of breast cancer characteristics, long done by hand under a microscope by pathologists, could soon by aided by a computer program as researchers have created a model that can accurately and automatically analyze breast cancer microscopic images, according to a paper published Nov. 9 in Science Translational Medicine.

RadNet, a network of fixed-site outpatient diagnostic imaging centers with over 200 locations nationwide, has acquired 21 imaging facilities in Maryland, Delaware and Rhode Island, which comprised the vast majority of the U.S. imaging operation of CML HealthCare.

Farzad Mostashari, MD, National Coordinator for Health IT, recently responded to a new Institute of Medicine (IOM) report that encouraged the U.S. Department of Health and Human Services (HHS) to develop a plan to minimize patient safety risks associated with health IT.

Medicare is adding coverage for a number of preventive services to reduce cardiovascular disease, according to the Centers for Medicare & Medicaid Services (CMS).

Digital breast tomosynthesis provided mass characterization comparable to mammographic spot views in terms of visibility ratings, reader performance and BI-RADS assessment, according to a study published online Oct. 13 in Radiology. The findings could set the stage for a new paradigm in clinical breast imaging practice that substitutes tomosynthesis for spot views and may spare women from diagnostic mammography recalls.