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Weekly News, Analysis, and Commentary

Legal & Regulatory Features & News

510(k) FDA Moneyball

Image created by RRY Publications, LLC
Image created by RRY Publications, LLC

Three experts on FDA data inspired by Moneyball-type statistical analysis look at the figures the agency has been touting about an improved 510(k) clearance program. The FDA averages look good. But averages can mask patterns. See what they found.

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Obamacare May Not Survive a 2nd Supreme Challenge

Photo creation by RRY Publications LLC / Sources: Pete Souza and U.S. Government
Photo creation by RRY Publications LLC / Sources: Pete Souza and U.S. Government

The Roberts Court wants a second look at Obamacare. Odds are it may not survive this vote. And in the process two legacies—the President’s and a U.S. Chief Justices’—may well be changed forever. And as that drama unfolds, the medical device tax repeal may well be able to slip through and get to Obama’s desk for signature. Read how.

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Spinal Cap III: The Taming of the Pedicle Screw – Part I

Photo creation by RRY Publications LLC / Sources: Wikimedia Commons and Kaudris
Photo creation by RRY Publications LLC / Sources: Wikimedia Commons and Kaudris

The whistleblower lawsuit that started the FBI Spinal Cap investigation in California has been made public. Michael Drobot is still at the center of this drama. Act III of the drama now unfolds as patients sue Drobot and his accomplices for causing counterfeit screws and rods to be implanted in their spines. Read Part 1 this week.