Due to an inspection of Edwards Lifesciences in Irvine, Calif., on Sept. 9, 2009, through Sept. 16, 2009, the FDA has sent a warning letter to the company, stating that its annuloplasty ring devices and its pericardial heart valve device are misbranded.

Since the FDA expanded indications for rosuvastatin (Crestor, AstraZeneca) in February, physicians have questioned its place in clinical practice, based on a perspective published in the April 7 issue of the Journal of the American Medical Association.

Last year, U.S. pharmaceutical sales reached $300.3 billion, rising 3.3 percent compared to 2008--5.1 percent over 1.8 percent--and the shift to generic brand drugs has significantly increased and affected market trends, based on a report published April 1 by IMS Health.

Cubist Pharmaceuticals is planning to stop investing in the clinical development of CB-500,929 (ecallantide) as a therapy to reduce blood loss in patients undergoing cardiac surgery using cardiopulmonary bypass.

After a long standing lawsuit involving Medtronic and Edwards Lifesciences, the U.S. District Court of the District of Delaware has ruled in favor of Edwards, rewarding the company $73.5 million, after finding Medtronic guilty of infringing upon Edwards' U.S. Andersen transcatheter heart valve patent. However, Medtronic said that it plans to appeal the jurys verdict in the case, filed February 2008, involving the CoreValve transcatheter aortic valve system.

The medical imaging informatics section of the Medical Imaging and Technology Alliance (MITA) has issued a whitepaper to policymakers, suggesting that the integration of medical images into patient records should be considered for inclusion in the meaningful use criteria as of 2013.

Cardiovascular and metabolic disease biotechnology company Via Pharmaceuticals has launched a strategic restructuring and financing of its resources related to research and development of its line of drug candidates, beginning with a workforce reduction and a $1.25 million draw from a new $3 million secured Note and Warrant Purchase Agreement with the company's principal stockholder.

Medtronic and AGA Medical have settled a patent infringement lawsuit filed by Medtronic in 2007 alleging that all of AGA's Amplatzer occluder and vascular plug devices infringe three of Medtronic's method and apparatus patents on shape memory alloy stents (U.S. Patent Nos. 5,190,546, 6,306,141 and 5,067,957, collectively known as "the Jervis patents").