FDAnews Device Daily Bulletin
Feb. 16, 2012 | Vol. 9 No. 33
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.
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.
The Chinese Department of Health has issued a safety alert for specific models of Philips Healthcare’s IntelliVue monitors.
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.
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.
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.
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.
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.
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.
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