Public confidence in the FDA is low and big changes may be in order to fix the system for approving and regulating drugs, according to a new report by the Institute of Medicine (IOM).

Initiated by the agency itself, the report concludes that Congress, the FDA and the pharmaceutical industry share responsibility for the problems and should bare the burden for developing and implementing solutions.

A new, private research group, the Center for Medical Technology Policy is being formed to provide healthcare clinicians, payers and policymakers with evidence on the effectiveness and safety of emerging surgical procedures, medical devices, diagnostics and biopharmaceuticals, according to a ModernHealthcare.com report.

Americans Andrew Z. Fire and Craig C. Mello have won the Nobel Prize in medicine Monday for their discover of “RNA interference,” a powerful way to turn off the effect of specific genes.

A Yahoo!News story reports that the technique is already being widely used in basic science as a way to study the function of genes, and it is being studied as a treatment for infections such as the AIDS and hepatitis viruses, as well as other conditions, including heart disease and cancer.

Researchers at the Technion Institute, Israel, are developing a new method that may prevent heart attacks following angioplasty, Reuters reported.

Still several years from commercial availability, the technique clears clogged arteries by administering a pill containing a "prodrug” that is only activated when it comes in contact with a specific enzyme attached to the stent. A precise amount of the drug is delivered to exactly the point it is needed.

FDA and Duke Clinical Research Institute will be working to develop a new generation of tools that enable early identification of potential cardiac side effects of drugs and devices. The agency will use a database comprising more than 200,000 ECGs to conduct the research.

ATS Medical, Inc., a manufacturer of cardiac surgery products and services focused, has announced completion of its acquisition of 3F Therapeutics, a privately held company that develops and commercializes fundamentally unique tissue heart valve products.

"We believe we are now well positioned to enter the tissue heart valve market with products that are differentiated from those that are currently available and that will offer outstanding benefits to surgeons and their patients," said Michael Dale, chairman, president and CEO of ATS Medical.

Zargis Medical Corp., a spin-off from Siemens Corporate Research and a majority-owned subsidiary of Speedus Corp., has announced that it was selected as a runner-up in The Wall Street Journal's 2006 Technology Innovation Awards.

Zargis was selected as a runner-up in the Medical Devices category for Cardioscan, the world’s first computer-aided stethoscope that aids physicians in identifying and evaluating murmurs and other heart sounds that may be indicative of cardiovascular disease.

Administering a cholesterol-lowering drug prior to heart bypass surgery or surgical repair of a faulty heart valve may reduce the occurrence of atrial fibrillation, a common heart rhythm disturbance triggered by these surgeries. The research was published in “Circulation: Journal of the American Heart Association.”

Researchers in The Netherlands say they’ve realized the dream of truly interactive 3-D medical imaging: A company called Crosslinks is working to develop and market a software invention in Europe and around the world that provides 3-D visualization that clinicians and researchers can not only view head-on, but actually walk around and through.

Final recommendations issued Sept. 28 from the Heart Rhythm Society are aimed at providing heart patients with clearer, timelier and more consistent information about the recall process and the performance of pacemakers and implantable cardioverter defibrillators (ICDs).

Offering specific guidance to physicians, Food and Drug Administration (FDA) officials and members of Congress about performance and advisory issues pertaining to implantable cardiac devices, the final recommendations report also addresses international principles related to device performance.

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