Healthcare Stories People Are Talking About
As we discussed earlier this week, the big news this week was the FDA’s announcement of its changes to improve the 510(k) market approval process for medical devices. The industry continues to come out and support the changes but the consensus during the Advanced Medical Technology Association (AdvaMed) conference call held yesterday cautions its listeners that the impact of the plan will depend on how the changes are implemented and whether or not it will improve patient access to new technologies. We along with everyone else in the industry will be playing close attention to how everything plays out.
Additional news stories making headlines this week include:
• An advisory committee to the FDA recommended unanimously that the FDA approve the first test — a brain scan — that can show the characteristics plaque of Alzheimer’s disease in the brain of a living person. However, this is conditional upon a training program be set up for physicians to properly read scans using the dye and that the company demonstrates that the images are being interpreted correctly. Avid Radiopharmaceuticals, a wholly-owned subsidiary of Eli Lilly, manufactures the dye. Typically, the FDA follows the advice of its panels. More than 5 million Americans suffer from Alzheimer’s disease and it is the second leading cause of death in the U.S. While there is currently no treatment that can slow or reverse the progression of the disease, knowing definitely if a person had it would be invaluable in enabling physicians to diagnose whether a patient’s memory problems are a result of Alzheimer’s disease or something else such as tiny strokes. This has huge implications for patients and their families, enabling them to best plan and understand what lies ahead.
• The U.S. House of Representatives passed a bill (H.R. 2) “The Repealing the Job-Killing Health Care Law Act aimed at repealing all aspects of Affordable Health Care Act, also known as “Obamacare.” Our blog post from earlier this week opines on what this means for medical companies and citizens.
Posted by Lauren Arnold on January 21, 2011 at 4:13 PM
