The FDA has approved a supplemental new drug application for Tradjenta (linagliptin, Boehringer Ingelheim Pharmaceuticals/Eli Lilly) tablets for use as add-on therapy to insulin.

Congressional lawmakers expressed concern with a flaw in an FDA regulatory process that expedites approval of medical devices similar to previously approved devices. A law requires the FDA to clear a device substantially similar to a predicate, even if the the updated model contains the same design flaws that caused the earlier model to be recalled.

The FDA approved ranibizumab injection (Lucentis, Genentech, which is a subsidiary of the Roche Group) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.

Toshiba America Medical Systems has received FDA clearance for its high-density 16-element coil system, developed in partnership with NeoCoil.

Average total hospital costs rose across the board for cardiovascular and cerebrovascular conditions and procedures between 2001 and 2010, according to an analysis by the Agency for Healthcare Research and Quality (AHRQ). In most categories, costs are projected to continue climbing through 2012.

All eyes are London for the next fortnight or so. U.S. athletes are competing spectacularly, piling on the medals. The official count stands at 18 gold, nine silver and 10 bronze medals. Teamwork and training are central to this performance.

The conventional wisdom holds that, when it comes to deploying new medical technologies, the U.S. is much slower than Europes four largest markets. The conventional wisdom is wrong. So argued the authors of an Aug. 1 New England Journal of Medicine Perspective article, basing their case on data showing that reimbursement decisions figure as prominently as regulatory ones in delayingor expeditingpatient access to innovative, high-risk devices.

St. Lukes University Hospital has ordered GE Healthcares Discovery IGS 730, a laser-guided system that received FDA clearance in February.