Medical Devices

A CMS advisory panel will discuss whether positron emission tomography imaging could be used to manage Alzheimer's at a meeting slated for Jan. 30, which will occur just two weeks after the agency is expected to decide whether to reverse its policy of not covering PET for any disease.

GOP presidential candidate Mitt Romney cited both FDA's “slow and opaque” approval process and the health reform-created medical device tax as policies that are impeding medical innovation, including development of new medical countermeasures, antibiotics and vaccines, in response to a series of questions posed to both presidential candidates on science policy by a group of leading science organizations.

Mandatory across-the-board government funding cuts might apply to FDA user fees and as a result lead to a bigger agency impact that initially thought, FDA funding advocates said in advance of an administration report set for release this week that will detail cuts to occur under the budget act's sequestration.

The U.S. Court of Appeals for the District of Columbia Circuit on Friday (Aug. 24) blocked FDA's attempt to implement cigarette warning label requirements, teeing up a potential for Supreme Court review as Friday's ruling conflicts with a different appeals court decision, according to several groups pressuring the government to continue defending the labels.

New draft guidance outlining FDA's refuse to accept policy for 510(k) medical device submissions could lead the agency to invoke its authority to block incomplete applications more frequently and encourage companies to submit more complete submissions, a change that could speed up review times, industry attorneys said following release of the user fee-mandated guidance.

CMS announced on Monday (August 13) that it is immediately discontinuing a hospital quality reporting measure used in determining whether hospitals properly care for heart-attack patients after FDA recalled devices that many hospitals were using to monitor compliance with the measure.

A group of 23 high-profile health policy experts on Wednesday (Aug. 1) floated far-reaching proposals to cut back health care spending that include moving to a system that would allow states to promote payment rates within a global spending target, requiring exchanges to be active purchasers and to offer at least one “tiered” product, using competitive bidding for all commodities in the federal health system and the insurance exchange, expanding the ban of self-referrals to cover private insurers, requiring full price transparency and encouraging less restrictive state scope of practice laws.

Emergency care groups applauded the National Institutes of Health for creating a new office for emergency care research and said the office, unveiled Tuesday (July 31) following years of discussions with stakeholders, was a significant advance for emergency medicine investigators and emergency patients.

Stakeholders said proposed FDA x-ray labeling, which cautions against the device's use in children if there is not data to back up the pediatric use, could force hospitals to use the devices off-label and proposed alternatives, including labeling with the intended use of the device.