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Weekly News, Analysis, and Commentary

BioGlass Is Back – In an Incredible New Form

Fibergraft / Courtesy: Prosidyan
Fibergraft / Courtesy: Prosidyan

Two of the most biologically active implants ever sold to orthopedic surgeons emerged from the U.S. government’s atomic energy research of the 1950s and 1960s. The first was Marshall Urist’s discovery of bone morphogenic proteins (BMP). The other is the subject of this article.

FDA Abused Power, ReGen Biologics Exonerated

Image created by RRY Publications, LLC / Source: cctpp.com
Image created by RRY Publications, LLC / Source: cctpp.com

A U.S. Court of Appeals called the actions of the FDA unlawful and exonerated ReGen Biologics of accusations of misconduct. Short of misconduct, the FDA has no power to rescind the 510(k) clearance of the company’s Menaflex collagen scaffold, said the Court. What does this all mean for your next encounter with the FDA? Read it here.

Freiberg v. Callaghan: Three Rounds Over Hip Bearing Alternatives

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

“Highly crosslinked polyethylenes have a very low wear rate and have reduced revision rates,” says Andrew Freiberg. “Let’s not forget,” says John Callaghan, “there are issues such as increased frictional torque and wear issues with larger heads.”

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Three Reasons Surgeons Make Poor Decisions // New Study: Academic Medical Centers Discriminate Against Medicaid Patients // and More!

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

New study finds that doctors are stuck in their ways…despite evidence that they should change. Medicaid patients near academic medical centers are treated differently than private pay patients. And a massive new study from the Netherlands raises concerns about new devices. (Hint: they are no better after all.)

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POD Lawyer to Feds: “Show Us the Evidence”

Source:  Patric Hooper – Hooper, Lundy and Bookman, P.C.
Source: Patric Hooper – Hooper, Lundy and Bookman, P.C.

The legal battle over PODs is getting heated. The lawyers are starting to threaten sanctions and lecturing each other over ethics. Pat Hooper, the lawyer for the defense is demanding to see the evidence. We obtained the latest exchange between the combatants. No anonymous leaks, just a very public battle.

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POD Defender Puts DOJ on Ropes

Source: U.S. Navy photo by Mass Communication Specialist Seaman Apprentice Matthew Bookwalter and Wikimedia Commons
Source: U.S. Navy photo by Mass Communication Specialist Seaman Apprentice Matthew Bookwalter and Wikimedia Commons

The government’s healthcare cop, the DOJ, says Reliance Medical violated the Anti-Kickback Statue of the False Claims Act. Rubbish, says Reliance’s lawyer, Pat Hooper who beat the DOJ the last time they went after physician owned entities. He says the government’s just coming back for a second bite of the apple. Read how he is defending his clients and PODs.

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