Regulatory Impact on Marketing Medical Devices/Equipment

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.

Seeking to rein in medical costs, a commission in Michigan on Wednesday moved to prevent hospitals in the state from each spending $100 million or more...

The consent decree prohibits the manufacture, distribution, and export of specified AEDs at or from Physio-Control's facility in Redmond, Wash., until the devices and facilities have been shown to be in compliance...

The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.

Federal regulators have approved the sale of a new laser scanning system intended to locate fatty deposits in blood vessel walls that are thought to cause heart attacks.