Topic: Food and Drug Administration

FDA: CardioMEMS device meets top study goals

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 ...

FDA sees rare but serious issue with stents

(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 ...

Exclusive: FDA sees rare but serious issue with stents

(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 ...

Exclusive: FDA sees rare but serious issue with heart stents

(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 ...

Newer birth control pills again tied to blood clots

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 shows higher clot risk: US

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 ...

ADHD drugs do not increase heart problems in kids: study

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 ...

AtriCure heart device safe, with caveats: FDA staff

(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 ...

GSK anti-nausea drug may pose risk to heart rhythm: FDA

(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 ...

Misunderstanding of drug approval common: study

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 ...