Category: OlympusSyndicate content

SEC settles with banker tied to Olympus accounting scandal

March 2, 2015 by MassDevice

The U.S. Securities & Exchange Commission settles civil charges against a banker implicated in the $2 billion accounting scandal that nearly sank Olympus.

SEC settles with banker tied to Olympus accounting scandal

Patients sue Olympus over superbug infections

February 26, 2015 by MassDevice

Lawyers for 2 patients, 1 of whom died, sue Olympus over the so-called 'superbug' infections they allegedly picked up from its endoscopes during surgical procedures.

Patients sue Olympus over fatal superbug infection

(Reuters) — Attorneys for 2 patients infected with a drug-resistant bacterial "superbug" during medical procedures in a Los Angeles hospital, 1 of whom died, have sued the maker of the devices used in their care.

FDA seeks to speed updates to "superbug" device labels

February 25, 2015 by MassDevice

Federal regulators will speed label changes for medical devices linked to the 'superbug' outbreak

FDA warns on pediatric use of bone growth proteins

(Reuters) - The U.S. Food and Drug Administration is working to speed label changes for medical devices linked to a "superbug" outbreak in California, possibly to include new warnings and more stringent cleaning and disinfecting instructions, a senior official said.

FDA warns on ERCP endoscope, CRE "superbug" link

February 20, 2015 by Val Kennedy

The FDA warns ERCP endoscopes may allow for the transmission of certain drug-resistant "superbugs," even if the devices are properly cleaned.

FDA warns on pediatric use of bone growth proteins

The FDA is warning that ERCP endoscopes may allow for the transmission of certain drug-resistant "superbugs," even if the devices are properly cleaned.

The advisory was issued in the wake of news that contaminated endoscopes are suspected of causing a deadly outbreak of the superbug CRE, or carbapenem-resistant enterobacteriaceae (CRE), among patients at the UCLA Ronald Reagan Medical Center in Los Angeles.

FDA knew devices spread fatal 'superbug' but does not order fix

February 20, 2015 by MassDevice

Regulators have known since at least 2009 that the medical devices at the center of the "superbug" outbreak at UCLA

FDA warns on pediatric use of bone growth proteins

(Reuters) - U.S. health regulators have known since at least 2009 that the medical devices at the center of the "superbug" outbreak at UCLA can transmit lethal infections but have not recommended any new safety requirements, a lapse that threatens patient safety, experts in hospital-acquired infections said.

Olympus in talks to end U.S. kickbacks probe

February 9, 2015 by MassDevice

Olympus says it's negotiating with the U.S. Justice Dept. to settle a fraud and kickbacks probe into its medical division.

Olympus in talks to end U.S. kickbacks probe

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Olympus accuses ex-sales manager, ArthroCare | Medtech legal news for the week of June 23, 2014

June 23, 2014 by MassDevice

Here's a look at some of the top legal news stories for medical device companies this week: Olympus goes after ex-sales manager, ArthroCare; Stryker alleges Medtronic colluded with patent troll for Kyphon IP; Investors fire life science VC Burrill from his own fund; Patient group wants J&J probe over pelvic mesh

Olympus goes after ex-sales manager, ArthroCare

June 16, 2014 by Brad Perriello

Olympus goes after ex-sales manager, ArthroCare