Consumers Union, the nonprofit publisher of Consumer Reports, has voiced pointed concerns to Congress over the new user-fee agreement between the FDA and manufacturers of medical devices.

.The FDA is notifying healthcare professionals, and in particular, the medical imaging community, about the planned return of CardioGen-82 to the U.S. market following the voluntary recall by the manufacturer, Bracco Diagnostics, on July 25, 2011. The agency has approved revised labeling for CardioGen-82 to include a boxed warning and enhanced testing information to help minimize the risk for exposure to unintended levels of strontium radiation.

Physicians will have another option when it comes to treating patients with coronary artery diseaseMedtronics Resolute Integrity Drug-Eluting Stent (DES). FDA approved the device Feb. 20.

Eight initiatives the FDA presented for public comment last October as part of its program to increase transparency have been finalized and adopted.

Stereotactic body radiotherapy (SBRT) provides better overall survival rates than surgery for lung cancer patients with severe chronic obstructive pulmonary disease (COPD), a disease commonly associated with lung cancer, according to a study in the upcoming March issue of the International Journal of Radiation OncologyBiologyPhysics.

Data from 3T MRI scans showed a distinctive pattern of white matter fiber tract development among high-risk infants who develop autism spectrum disorders (ASDs), according to a study published online Feb. 17 in American Journal of Psychiatry. The findings raise the possibility of an imaging biomarker for autism risk, according to researchers.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion in the European Union (EU) for the expanded use of Byetta (exenatide twice-daily, Amylin Pharmaceuticals/Eli Lilly) as an add-on therapy to basal insulin, with or without metformin and/or pioglitazone (Actos), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.

The Class I recall of the Riata and Riata ST silicone defibrillation leads exposes weaknesses in the FDAs postmarket surveillance capabilities, according to a perspective published Feb. 14 in the New England Journal of Medicine. Until surveillance systems for monitoring lifesaving devices are in place, the onus is on  manufacturers to conduct postmarketing studies that spot problems early and provide clinical evidence to inform patient care, the author argued.