Codman Neuro, a division of Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes, said the FDA labeled its Trufill n-BCA liquid embolic system recall as Class I, the federal watchdog agency’s highest-risk classification.
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Orthopedic company Symmetry Medical (NYSE:SMA) signed a definitive agreement to acquire the surgical instrument business of Johnson & Johnson (NYSE:JNJ) subsidiary Codman & Shurtleff for $165 million cash.
Symmetry plans to integrate its current hospital direct business, Specialty Surgical Instrumentation, with Codman’s line of surgical instruments.
Abbott (NYSE:ABT) won CE Mark approval for its FreeStyle InsuLinx blood glucose monitor, its first to include a mealtime (bolus) insulin calculator.
The Abbott Park, Ill.-based health care leviathan said it plans to have the system on the 55.4-million-patient market in Europe this month, beginning with Belgium, France, Germany, Netherlands, and the United Kingdom.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
A former sales rep for Exactech Inc. avoided prison but landed five years’ probation and $56,000 in fines after pleading guilty to setting up a kickbacks scheme to encourage orthopedic surgeons to use the company’s hip and knee implants.
Judge Garrett Brown of the U.S. District Court for New Jersey handed down the sentence to Douglas Donofrio, the former New York-area sales director for the Gainesville, Fla.-based company. Donofrio pleaded guilty to running the scheme between 2002 and 2008.