Regulatory Impact on Marketing Medical Devices/Equipment

In February, Boston Scientific said the Justice Department was investigating whether manufacturers had been promoting the devices for unapproved uses, among them the repair of weakened blood vessels.

The improvements include stricter limits on financial conflicts of interest for committee members, ...

It is one of the most audacious promises in a campaign that has been thick with them.

European Union residents would be able to receive most health care treatment anywhere in the 27-nation bloc without prior authorization under a proposal published on Wednesday.

Device can help paralysis patients breathe without a ventilator for at least four hours

Two letters signeed by 132 members of Congress urge a delay in the Medicare bidding program for home medical equipment.

We are moving from reactive dependence on voluntary reporting of safety concerns -- to proactive surveillance of medical products on the market.

The 60-second ad for the Cypher stent, made by the Cordis subsidiary of Johnson & Johnson, failed to adequately warn consumers about the potential dangers...

Millions of people with asthma and other lung diseases will have to switch inhalers by the end of the year. And for many, the transition will not be smooth.