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
The FDA has approved the start of outpatient trials of a smart phone-based monitoring device that functions as an artificial pancreas.
Finally some good news for Type 2 Diabetics, drug makers Bristol-Myers Squibb and partners Astrazeneca PLC had their latest drug Onglyza approved. Onglyza reduces blood sugar levels in patients with type 2 diabetes, which affects 24 million people in the U.S. The drug is the first to gain approval since the agency issued new testing […]