Feb. 16, 2012

Vol. 9 No. 33

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Last of Individual Charges Dropped in Stryker Off-Label Case

The government’s decision to drop charges against all four Stryker officials indicted in a bone product off-label promotion scheme could serve as a “cautionary flag” in future cases, attorneys for one of the men say. Read More

Canada Updates Guidance on Women in Clinical Trials

An updated Health Canada guidance provides advice on when to include or exclude women from device and drug trials, including women who are pregnant or breastfeeding. Read More

Philips Issues Safety Alert for IntelliVue Monitor

The Chinese Department of Health has issued a safety alert for specific models of Philips Healthcare’s IntelliVue monitors. Read More

Organizations Blast Imaging Cuts in Obama’s Budget

The Access to Medical Imaging Coalition, American College of Radiology and the Medical Imaging & Technology Alliance have protested the Obama Administration’s proposed budget for 2013, which contains imaging cuts projected to save $820 million over 10 years. Read More

St. Jude Medical Heart Device Recall Lacks Data for Patients, Cardiac Expert Says

A prominent heart doctor in Minneapolis is calling on St. Jude Medical to initiate a study that could help physicians care for thousands of patients currently implanted with a medical device that was recalled last year. Read More

Blood Therapy Devices Eye PC-to-Copolyester Switch

Some manufacturers of blood therapy and management equipment are exploring conversion from polycarbonate to copolyester compounds in an apparent effort to avoid contamination from bisphenol A, a feedstock used to make polycarbonate. Read More

HeartWare Gains After Landing a Date With the FDA

HeartWare International shares closed up 2.4 percent after the company won a hearing date before the FDA’s circulatory system devices panel in April. Read More

Velomedix Nets IDE to Study Hypothermia in Acute MI Patients

Velomedix received investigational device exemption approval from the FDA to evaluate the use of therapeutic hypothermia for the treatment of patients suffering an acute MI. Read More

Cardio Device Gives Sierra Vista Man Second Chance

After a lifetime in the Army, then a career with the Sierra Vista Police Department, John Clabourne was a healthy example of the benefits that result from living right when he retired in 2004. Read More