NeuroMetrix, Inc., a Massachusetts-based medical device company, has filed a 510(k) form with the US Food and Drug Administration for the SENSUSTM, a pain therapy device for people who suffer diabetic neuropathy. A 510(k) is a "premarket notification" of a company's intent to market a medical product. The FDA then tests the product and provides feedback to the manufacturer. Once the FDA clears the product, its maker can introduce it to the US market.
The latest clinical guidelines for treating type 2 diabetes from the American College of Physicians (ACP) indicate that when diet, exercise, and weight loss fail to control blood sugar levels in early type 2 patients, physicians should prescribe metformin as the first drug therapy.
You've heard of the blockbuster drug Byetta, a daily injection for type 2 diabetes? Byetta's sister product, Bydureon, which is injected just once a week, has just been approved by the FDA and is available in pharmacies.
There are lots of articles about diabetes, as well as all kinds of information about anemia. But what if you have both? About 25 percent of people with diabetes have some level of anemia. This article explains how the two conditions interact.
After several years of delays and setbacks, Amylin Pharmaceuticals has received FDA approval to begin US marketing of BydureonTM. The first once-a-week type 2 therapy to be offered in the US market, Bydureon is expected to be available by February. Amylin says that its wholesale price will be about $4,200 a year.
Animas Corporation, a division of Johnson & Johnson that manufactures insulin pumps, has been reprimanded by the FDA for not reporting serious problems resulting from use of its equipment. The parent company was warned that it could face fines and more for selling faulty insulin pumps and failing to disclose serious injuries to diabetic patients who used the OneTouch Ping and 2020 insulin pumps. According to reports, J&J continued to sell the pumps even after the company knew that some had failed.
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