This month, the FDA released its first framework for the regulation and oversight of nanotechnology, as a joint collaboration with the National Economic Council, the Office of Management and Budget, the Office of Science and Technology Policy and the Office of the U.S. Trade Representative. This is a "first step" towards regulating this new and innovative technology.

The groundbreaking CREST trial resulted in an expansion of carotid artery stenting (CAS) to patients at standard risk for adverse events during surgery. While the results were mostly positive, there was a higher risk of stroke after CAS and a higher risk of MI after carotid endarterectomy (CEA). Researchers have now reported that both MI and biomarker+ were more common with CEA and although these levels were modest, these events were independently associated with increased mortality, according to a substudy of the CREST trial published June 21 in Circulation.

Texas Governor Rick Perry signed into law HB 2102, which requires mammography facilities to provide women information about breast density, on June 17.

An updated analysis of studies evaluating the clinical and biochemical outcomes of radiation therapies for clinically localized prostate cancer revealed a lack of high-quality evidence regarding the efficacy of radiation treatment compared with no treatment, according to a review published June 6 in Annals of Internal Medicine. The authors called for additional research to demonstrate or disprove the effectiveness of radiation therapy versus no treatment.

As part of a new strategy to keep up with imported regulated products, the FDA said it will work with international regulatory bodies to foster safe product development globally. The agency said the strategy, titled Pathway to Global Product Safety and Quality, includes developing international data information systems and networks to share regulatory resources across world markets.

The FDA has approved Endologixs AFX endovascular abdominal aortic aneurysm (AAA) system, an endovascular repair of abdominal aortic aneurysm device indicated to treat AAA. 

Researchers at Fred Hutchinson Cancer Research Center in Seattle have demonstrated in mice that the performance of a novel biomarker-development pipeline using targeted mass spectrometry is robust enough to support the use of an analogous approach in humans, based on findings by principal investigator Amanda Paulovich, MD, PhD, an associate member of the Hutchinson Center's clinical research division, and colleagues published in Nature Biotechnology.

The FDA has issued draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the U.S.