Topic: Food and Drug Administration
GAITHERSBURG, Maryland (Reuters) - U.S. health regulators are taking a closer look at how well devices used by diabetics to monitor their blood sugars work, seeking possible changes for device makers to help make them more reliable. At a two-day meeting to review blood glucose meters, Food and Drug Administration officials and staff pointed to a number of issues that ...
The Food and Drug Administration voiced several complaints Tuesday with Medtronic's study of a new pacemaker that can be used in an MRI machine. Patients with pacemakers are generally discouraged from having MRI scans because the radio waves could interfere with the functioning of their device. Medtronic has asked the FDA to approve its REVO Surescan pacemaker as the ...
In a story March 15, The Associated Press reported that Bydureon is the proposed trade name of exenatide, a diabetes treatment being developed by Amylin Pharmaceuticals Inc., Eli Lilly & Co. and Alkermes Inc. The story should have specified that the once-weekly form of the drug, exenatide LAR, would be called Bydureon. A daily ...
The Food and Drug Administration said Tuesday a heart device from Boston Scientific appears effective for a new group of patients, though questions remain about the accuracy of the company's study of the device. Boston Scientific has asked the FDA to approve its heart rhythm device to treat mild heart failure, a new use that could expand the market ...
