Three government agencies will collaborate to develop a chip to screen drugs faster and more efficiently than current methods for safety and effectiveness, according to a Sept. 16 statement from President Barack Obama. The National Institutes of Health (NIH), the Defense Advanced Research Projects Agency (DARPA), and the FDA will develop the chip to carry specific cell types that reflect human biology to report on whether specific compounds are toxic to humans.

One of the variables with the effects of cancer is hypoxia, and a PET-based imaging technique may be capable of measuring and mapping it. Researchers at Washington University in St. Louis are focusing on two aspects of the investigational PET probe Cu-62 ATSM for hypoxia imaging.

Spinal digital subtraction angiography (SpDSA) carries a very low risk of complications, and provides the imaging gold standard for the evaluation of spinal cord disorders, according to a study published online Sept. 14 in Neurology. The results contradict the perception of SpDSA as a high-risk procedure that requires high doses of radiation and contrast.

The number of new cases of breast cancer diagnosed worldwide has risen dramatically from about 640,000 in 1980 to 1.6 million in 2010. During the same period, cervical cancer incidence and death rates have been decreasing, but the disease still killed 200,000 women in 2010, according to the first global estimates published Sept. 14 in The Lancet. The report shows that, in 2010, 51 percent of the 1.6 million new cases of breast cancer and 76 percent of the 425,000 new cases of cervical cancer occurred in developing countries.

The FDA has released draft guidance clarifying when device modifications trigger the need for a new premarket review, or 510(k) submission. When finalized, it will supersede the previous 1997 guidance on the subject.

The rates of new lung cancer cases in the U.S. dropped among men in 35 states and among women in six states between 1999 and 2008, according to a report by the Centers for Disease Control and Prevention (CDC). Among women, lung cancer incidence decreased nationwide between 2006 and 2008, after increasing steadily for decades. Smoking cessation fueled the decline and other data have suggested CT screening could motivate smokers to quit.

Comments on a proposed rule to relax sterility test requirements for biological products must be submitted to the FDA by Sept. 19. Published June 21 in the Federal Register, the proposal is aimed at increasing flexibility for manufacturers by encouraging state-of-the-art methods, and includes elimination of specified sterility test requirements.

In response to the FDA's invitation to participate in a public workshop related to FDAs Draft Guidance on mobile medical apps, AMIAthe association for informatics professionalsadvised the agency on how it should approach oversight of clinical decision support (CDS) systems.