Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Sunday, June 21, 2015

Blind Americans can now ‘see’ with a device that uses their tongues

Blind Americans can now ‘see’ with a device that uses their tongues


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The three-part device BrainPort V100 will cost about $10,000.
IMAGE: WICAB VIA BLOOMBERG
 
A new device that helps the blind "see" by using their tongues has been approved by the U.S.Food and Drug Administration.
The BrainPort V100, cleared for 250,000 profoundly blind Americans without sensitivity to light, will cost about $10,000, said Robert Beckman, chief executive officer of closely held Wicab Inc.The three-part device captures images with a camera mounted on sunglasses, routes them through a hand-held controller and sends them to a 1-inch square device containing 400 electrical stimulation points that rests on the user's tongue.
"People are able to learn to interpret these patterns of bubbles or stimulation on their tongue to know what object is in front of them," Beckman said. "We don't want to create false hopes," he said. "They need to learn the technology and practice with it. It's more akin to learning a new language than it is to ordinary perception."
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People using the BrainPort for the first time can often walk around an oval track, staying within the white lines without assistance, Beckman said. With additional training, they can navigate hallways, read short words such as EXIT, tell the difference between a ball and a banana, and eventually play darts, he said. The BrainPort was approved for use in Europe in 2013, according to the company's website.
"Medical device innovations like this have the potential to help millions of people," said William Maisel, deputy director for science at the U.S. Food and Drug Administration. "It is important we continue advancing device technology to help blind Americans live better, more independent lives."

Brain stimulation

Studies show that people who are blind perceive the electrical stimulation in their visual cortex, the part of the brain responsible for sight. People using the BrainPort who aren't visually impaired process it as tactile information, Beckman said.
Google Inc. and the U.S. Department of Defense helped fund the device's development. Wicab, based in Middleton, Wisconsin, licensed a patent on the device from the Wisconsin Alumni Research Foundation, a nonprofit patent and licensing organization for the University of Wisconsin at Madison.
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The company hopes to gain insurance reimbursement for the device, though it acknowledges that adoption of the technology may be slow going, especially at first.
"The reality is that most people who are profoundly blind are also quite poor," Beckman said. "It will take off slowly just because of blind people being so impoverished."
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Saturday, June 20, 2015

FDA officially bans trans fats

FDA officially bans trans fats


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Most artificial trans fats have already been removed from the food supply.
IMAGE: CARLOS OSORIO/ASSOCIATED PRESS
WASHINGTON — The Obama administration is cracking down on artificial trans fats, calling them a threat to public health.
The Food and Drug Administration said Tuesday that it will require food companies to phase out the use of artificial trans fats almost entirely. Consumers aren't likely to notice much of a difference in their favorite foods, but the administration says the move will to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.
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Scientists say there are no health benefits to trans fats, which are used in processing food and in restaurants, usually to improve texture, shelf life or flavor. They can raise levels of "bad" cholesterol and lower "good" cholesterol, increasing the risk of heart disease, the leading cause of death in the United States. The fats are created when hydrogen is added to vegetable oil to make it more solid, which is why they are often called partially hydrogenated oils.
Once a staple of the American diet — think shortening and microwave popcorn — most artificial trans fats are already gone.
Once a staple of the American diet — think shortening and microwave popcorn — most artificial trans fats are already gone. The FDA says that between 2003 and 2012, consumer trans fat consumption decreased an estimated 78 percent as food companies have used other kinds of oils to replace them.

Still, the FDA says that those trans fats remaining in the food supply are a public health concern. To phase the fats out, the FDA made a preliminary determination in 2013 that trans fats no longer fall in the agency's "generally recognized as safe" category, which covers thousands of additives that manufacturers can add to foods without FDA review. The agency made that decision final Tuesday, giving food companies three years to phase them out.
Now that trans fats will be off the list of safe additives, any company that wants to use them will have to petition the agency to allow it. That would phase them out almost completely, since not many uses are likely to be allowed.
Still, food companies are hoping for some exceptions. The Grocery Manufacturers Association, the main trade group for the food industry, is working with companies on a petition that would formally ask the FDA if it can say there is a "reasonable certainty of no harm" from some specific uses of the fats. A spokesman for the group would not specify what the industry plans to ask for, but said the FDA encouraged food companies to submit a petition.
Trans fats are widely considered the worst kind for your heart, even worse than saturated fats, which also can contribute to heart disease. Over the years, they have been used in foods like frostings, which need solid fat for texture, or in those that need a longer shelf life or flavor enhancement. Popular foods that have historically contained trans fats are 
pie crusts, biscuits, microwave popcorn, coffee creamers, frozen pizza, refrigerated dough, vegetable shortenings and stick margarines
pie crusts, biscuits, microwave popcorn, coffee creamers, frozen pizza, refrigerated dough, vegetable shortenings and stick margarines.

Trans fats also have been used by restaurants for frying. Many larger chains have stopped using them, but smaller restaurants may still get food containing trans fats from suppliers.
The industry's reduction in trans fats was helped along by FDA's decision to force labeling of trans fats on food packages in 2006. There have also been local laws, like one in New York City that restricts the fats in restaurants. Retailers like Wal-Mart have reduced the amount they sell.
The FDA has not targeted small amounts of trans fats that occur naturally in some meat and dairy products, because they would be too difficult to remove and aren't considered a major public health threat on their own.