Continued from page 2

“Physicians can now access this unique and innovative 3-D technology that could significantly enhance diagnosis and treatment approaches,” said Jeffrey Shuren, director of the FDA’s device division, in a statement.

The FDA approved the device based on two studies in which X-ray specialists demonstrated a 7 percent improvement in spotting cancerous tumors when viewing images from Hologic’s device, compared with traditional 2-D images. Such images can cause visibility problems owing to overlapping skin, which can hide tumors or create the appearance of tumors where there are none.

Approximately one in eight women will be diagnosed with breast cancer in her lifetime, according to the National Cancer Institute. The institute recommends women ages 40 and older have a mammogram every one to two years.

The Selenia device is already approved in Europe, Latin America and Asia.

Hologic is based in Bedford, Mass.


Feds widen probe into VW diesels

grows wider

The government’s highway safety agency expanded its investigation Friday into possible engine problems in 100,000 Volkswagen diesel cars.

The National Highway Traffic Safety Administration said it has received 160 complaints and field reports about engines stalling or losing power. The reports involve 2009 and 2010 model year Jettas and 2010 models of the Golf and the Audi A3 with TDI clean-diesel engines.

The safety agency said one minor crash has been reported related to a failure of the car’s high-pressure fuel pump. About half of the reports describe engines stalling, with many of them occurring at highway speeds in traffic.

Volkswagen told the government that the problem could be related to gasoline contamination from drivers pumping the wrong fuel. A VW spokeswoman said Friday it was taking the investigation seriously and cooperating with NHTSA.

The investigation began in August. NHTSA said it would upgrade its investigation to review the design of the high-pressure fuel pump and the reports of motorists using gasoline fuel in the diesel engines.


Panels asked to ID job-killing regulations

Story Continues →