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Clearly feeling rather upstaged by the FDA's approval of the AbioCor artificial heart from Abiomed (Danvers, Massachusetts) last month, Syncardia (Tucson, Arizona) was miffed.
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Physicians may soon have a means for earlier identification of patients who may be at risk for heart attack, through evaluation of what is now believed to be a key contributor to the problem, vulnerable plaque.
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The FDA last month notified the American Red Cross (ARC; Washington) of its intent to levy a $4.2 million fine against the blood collection agency following a review of recalls conducted between 2003 and 2005 that disclosed violations of the terms of a 1993 consent decree.
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David Bruce was named president/CEO of EP MedSystems (West Berlin, New Jersey). Previously Bruce was general manager at the Ultrasound Division of Siemens. EP MedSystems makes cardiac electrophysiology products to diagnose and treat cardiac rhythm disorders.
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The world of a prisoner in a correctional institution is all about control, or the lack of it. The time you wake up, when you eat, where you go, whom you speak to all is controlled by officers.
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While IRBS wait to learn the final outcome of the federal government's review of regulations for research involving prisoners, there are steps they can take right now to improve the review of these types of studies, say experts in the field.
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Every research institution wants to know that its participants have made a fully informed, unpressured decision to enroll in research. But, often, that basic question is hard to determine.
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When IRBs review protocols involving social-behavioral research, it's a good idea to define what IRB members believe are reasonable protections.
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Experts say there may be some opportunities missed in research with pregnant women. Despite some concerted government efforts that have succeeded in increasing research in this area, major industry sponsors shy away from this population.
