Smiths Medical has initiated a nationwide voluntary recall of Bivona Neonatal, Pediatric and FlexTend Tracheostomy Tubes with an integrated connector that is not designed to be used with a disconnect wedge.

Different ingredients in marijuana appear to affect regions of the brain differently during brain processing functions involving responses to certain visual stimuli and tasks, according to a study published in the January issue of Archives of General Psychiatry.

The FDA has issued draft guidance to clarify current review practices of premarket notification 510(k) submissions for FDA staff and manufacturers of medical devices.

GE Healthcare has paid the U.S. $30 million, plus interest, to settle allegations that a company it acquired in 2004, Amersham Health, had violated the False Claims Act by causing Medicare to overpay for Myoview, a radiopharmaceutical used in certain cardiac diagnostic imaging procedures, according to the U.S. Department of Justice.

Janssen Research & Development, a Johnson & Johnson company, has submitted a supplemental new drug application to the FDA seeking approval for the use of rivaroxaban (Xarelto), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).

Two oh one two. Among many rituals, practicing the change in date is a common exercise after we enter the New Year. At Cardiovascular Business, we have been looking forward to 2012 and beyond in many magazine and web articles. The selection in our final newsletter for 2011 features editor favorites, many of which provided a glimpse into the medical, regulatory and economic climate in the near future.

The U.S. House of Representatives, in a vote of 229-193, rejected the bipartisan Senate bill H.R. 3630, which included a two-month extension to the payroll tax cut and a fix to the sustainable growth rate. Instead, the House Republicans are insisting on a year-long extension of the tax cut.

A review of published literature on randomized controlled trials (RCT) investigating the effectiveness of medication management IT revealed many gaps and inconsistencies.