The Food and Drug Administration is modernizing the way it reports recalls of products that pose risks to consumers. Through the development of an application programming interface, all recalls reported to the Recall Enterprise System now will be available to researchers. The development of the software is significant because hundreds […]
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A lot can be misconstrued in the silent world of the Internet. While online technology has changed the communications paradigm, it also has resulted in bad information, embarrassing typos, factual errors and malfeasance. Fake Web sites, botched emails, rambling blogs and photo abuse appear in cyberspace every day. Most of […]
Medical devices are big business in America. They are not quite as big a business in Europe and other countries, but manufacturers can still sell a $400 hip implant for several thousands of dollars. Joint replacements have increased significantly between 1997 and 2011. As we baby boomers continue to age […]
For a diabetic, accurately monitoring his blood sugar level can mean a matter of life or a diabetic coma. So this latest warning from healthcare giant Johnson & Johnson is especially troublesome. Its popular OneTouch Verio IQ blood glucose meters have been found to be faulty when the blood sugar […]
On March 10, 2010, the Stryker Orthopaedics Division announced the release of a new hip replacement, the ADM X3 Mobile Bearing Acetabular System. Calling it the “next-generation of technology” in hip replacements, the company announced that Hall of Famer, Johnny Bench, would become the first patient in the world to […]
It is all about research and publishing. That is the pressure supposedly exerted on academics, scientists and some physicians – “publish or perish”. Scientific research is no different than any other form of research from the perspective of “garbage in garbage out”. These days most of us do some form […]
Searcy Denney Scarola Barnhart & Shipley has developed and launched a new website designed to provide consumers and clients with valuable information about a potentially dangerous drug — Pradaxa. Searcy Denney believes that consumers deserve to be well informed about drugs, medical devices and products in order to prevent unnecessary […]
“Quid pro quo” happens in business all the time. You scratch my back, I’ll scratch yours. Usually, the exchange is relatively even and the result doesn’t really cause any harm to anyone… or at least any harm of real consequence. But, give me a million dollars for my “quo” and […]
Over the past decade, the Food & Drug Administration has made great efforts to provide improved safety information to patients and consumers. The FDA web site includes a number of helpful materials: warning labels, podcasts white papers prepared for scientific panels that summarize complex medical and scientific data Power Point […]
We have written about the Food & Drug Administration process for “quickie” approval of medical devices provided for in the “501(k) approval process”. This involves a manufacturer asking for approval of its medical device because it is “similar to those already cleared” for use by patients. The 501(k) process allows […]