Topic: Food and Drug Administration
WASHINGTON (Reuters) - A Food and Drug Administration review of CardioMEMS' device for treating heart failure found it has met its main safety and effectiveness goals, based on trial results.But the FDA questioned on Monday how clinically significant the findings are for ...
(Reuters) - Health regulators are investigating a rare but potentially serious problem with a newer class of heart stents that causes the tiny tubular devices made of wire mesh to shrink, or lengthen, after implantation.The problem appears to occur most frequently in ...
(Reuters) - Health regulators are investigating a rare but potentially serious problem with a newer class of heart stents that causes the tiny tubular devices made of wire mesh to shrink, or lengthen, after implantation.The problem appears to occur most frequently in ...
(Reuters) - Health regulators are investigating a rare but potentially serious problem with a newer class of heart stents that causes the tiny tubular devices made of wire mesh to shrink, or lengthen, after implantation.The problem appears to occur most frequently in ...
NEW YORK (Reuters Health) - A study out Monday adds to evidence that a newer type of birth control pill may carry a higher risk of blood clots than older versions.The study, of 330,000 Israeli women, found that those who used birth ...
Some birth control products, including contraceptive pills, rings and patches for women, carry a significantly higher risk of blood clot than low-dose medications, US regulators said Thursday.The US Food and Drug Administration said in its review of studies that have included more ...
CHICAGO (Reuters) - Stimulants used to treat attention deficit hyperactivity disorder do not increase the risk of heart attacks, strokes or sudden death, U.S. researchers said on Monday, in a finding that should reassure millions of parents whose children take the drugs.Researchers ...
(Reuters) - AtriCure Inc's device for treating a heart rhythm disorder is safe and effective, but its trial size and design raise some concerns, U.S. Food and Drug Administration researchers said.AtriCure Synergy Ablation System is approved for ablation of heart tissue during ...
(Reuters) - U.S. health regulators said they are reviewing the safety of GlaxoSmithKline's anti-nausea drug Zofran to ascertain whether there is a potential risk of abnormal hearth rhythm.The drug may increase the risk of developing abnormal changes in the electric activity of ...
NEW YORK (Reuters Health) - Many people believe that drugs given the okay by the Food and Drug Administration are safer and more effective than they have to be to win approval, according to a new study.Especially in the first few years ...