Topic: Food and Drug Administration
BOSTON (Reuters) - U.S. regulators have requested more information on an inhaled insulin device being developed by MannKind Corp, sending the company's shares down 24.7 percent. MannKind said on Monday that it had received a so-called complete response letter from the Food and Drug Administration, which has been considering whether to approve the product, a whistle-sized device designed ...
Medical device maker Boston Scientific said Monday it is suspending sales of its heart-shocking defibrillator implants after failing to alert regulators to changes in manufacturing of the best-selling devices. The company said it uncovered two production changes that were not cleared with the Food and Drug Administration. Medical device makers are required to alert regulators to significant changes in life-sustaining ...
ATLANTA (Reuters) - Adding a drug that lowers blood fats known as triglycerides to cholesterol-fighting statins provided no additional protection from heart attack, stroke and death from heart disease in patients with Type 2 diabetes, according to data from a large study. The study run by the National Institutes of Health, dubbed Accord, aimed to see if the dual-drug therapy could ...
An experimental ablation therapy system that freezes heart tissue with a balloon catheter to treat a common heart rhythm disorder is far more effective than drug therapy, a study found Monday. Researchers compared the safety and efficacy of the Arctic Front CryoAblation Catheter System produced by US firm Medtronic to drug therapy over at least one year in 245 patients ...
