FDAnews Device Daily Bulletin

Companies could get a better idea of what the FDA expects in postapproval studies (PAS) required as part of a device’s approval at an Aug. 30 agency workshop.

MAQUET Medical updated its voluntary recall information for the C20, C30 and C40 FLOW-i anesthesia systems after the FDA declared them Class I recalls.

Inpatient hospital treatment accounts for the largest proportion of health care spending in the U.S., with the use of diagnostic imaging services such as MRI, frequently implicated as the probable cause. 

Medtronic has reached two clinical program milestones for its CoreValve System in the United States.

First the Republicans claimed President Obama’s health care law taxes “sick puppies,” and now Mitt Romney’s campaign claims the law taxes “wheelchairs.” Wrong again.

Johnson & Johnson’s DePuy subsidiary may see some relief from the ever-accumulating lawsuits over recalled metal-on-metal hip implants if states and judges decide to uphold a two-year statute of limitations on filed claims.

Medtronic, the global medical technology leader, announced today the official opening of its Innovation Center in Shanghai, China.

Covidien has announced it has received FDA clearance for a new stapling system.