The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective Oct. 1, 2012. To assist the medical device industry, Registrar Corp has provided the following list of top 10 things that medical device professionals need to know regarding FDASIA:

GE Healthcare, a business division of General Electric Company, announced it is joining with RadNet, a network of outpatient diagnostic imaging centers, to pilot its Best Pathways initiative, a breast cancer detection optimization model. GE Healthcare and RadNet will evaluate the clinical breast cancer detection process to quantify inefficient diagnostic patterns and identify optimal paths to lower cost and improve patient outcomes. This program will focus on subpopulations of women in which guidelines are lacking and substantial variability is observed in clinical practice.

September 19, 2012 — Heart catheter procedures guided by magnetic resonance imaging (MRI) are as safe as X-ray angiography-guided procedures and take no more time, according to a pilot study conducted at the National Institutes of Health (NIH). The results of the study indicate that real-time MRI-guided catheterization could be a radiation-free alternative to certain X-ray-guided procedures.