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FDA recommendations to retool the 510(k) program will likely add to industry’s burden to bring innovative products to market. In Part Two of our three part series, law professor Ralph Hall and AAOS member Bill Mihalko, M.D., give their opinions on what these recommendations will mean for industry and physicians.
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There are some patients who are not mentally healthy enough to undergo spine surgery, say our experts. And a particular screening tool—psychological testing—is not widely used. How might such tools aid orthopedists in surgical decision making?
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The FDA’s 510(k) clearance program has been 99.78% successful in keeping unsafe products from reaching the public. On August 3, the agency released 70 recommendations to retool the program. If the program works, why does it need an overhaul? Read the first of our three-part series.
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With orthopedic wait times longer than in other specialties, and the fact that a dissatisfied patient is less likely to refer you, it is important that the issue of wait times be addressed creatively.
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Drs. Charles Fisher and Christopher Bono discuss the orthopedic researcher’s “Plan B”—systematic reviews of the literature. What is the purpose? The process? What obstacles do researchers encounter? Hint: the study question is key.
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Depending on your political views, Donald Berwick, M.D., the new head of CMS, is either a medical socialist or thoughtful quality guru who will help fix an out of control federal health care budget. How his views will impact federal health care spending is unknown. See what we found.
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Robert Goldberg, M.D., wanted his day in court. He got it and lost. Now he’s amending a whistleblower suit to make his case in a new court—the court of public opinion. He’s accusing former colleagues of cheating Medicare. The government hasn’t joined in. His former colleagues say he has a vendetta. It’s an Ortho Rumble, Chicago style.