Tag Archives: U.S.

Olympus unit pleads guilty to resolve U.S. duodenoscope probe

(Reuters) – An Olympus Corp subsidiary pleaded guilty on Monday and agreed to pay $ 85 million to resolve charges that it failed to file reports with U.S. regulators regarding infections connected to its duodenoscopes while continuing to sell the medical devices used to view the gastrointestinal tract. Olympus Medical Systems Corp and Hisao Yabe,… Read More »

CanGaroo Envelope Now Cleared in U.S. to Protect Implantable Neurostimulators

Aziyo Biologics, out of Silver Springs, Maryland, won FDA clearance for its CanGaroo Envelope to be used with implantable neurostimulators. It has previously been cleared only for encapsulating implantable cardiac devices such as pacemakers and defibrillators. The CanGaroo Envelope is, contrary to what its name may imply, is a porcine extracellular matrix, essentially pig’s tissue with… Read More »

Novartis abandons effort for U.S. approval of biosimilar rituximab

FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo (Reuters) – Novartis International AG said on Friday that its Sandoz division is abandoning an effort to gain U.S. regulatory approval for a biosimilar of rituximab, a medication used… Read More »