Category: Fujifilm Medical Systems U.S.A. Inc.Syndicate content

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.

Supreme Court declines to hear appeal by Mirowski Family Ventures | Medtech legal news for the week of October 20, 2014

October 20, 2014 by MassDevice

Here's a look at some of the top legal news stories for medical device companies this week: Supreme Court passes on Mirowski-Medtronic patent case; Medtronic can't shake shareholders lawsuit over Infuse; FDA strikes out again in Prevor drug-or-device case; Ex-Bard, BD engineer gets 18 months for stealing trade secrets; Appeals court: Fujifilm Medical executive wasn't fired for not being Japanese

Supreme Court passes on Mirowski-Medtronic patent case

October 15, 2014 by Val Kennedy

Appeals court: Fujifilm Medical executive wasn't fired for not being Japanese

October 16, 2014 by Val Kennedy

A federal appeals court rules in favor of Fujifilm Medical Systems in a case filed by a former senior executive alleging he was fired because he was not Japanese.

Appeals court: Fujifilm Medical executive wasn't fired for not being Japanese

A federal appeals court ruled in favor of Fujifilm Medical Systems in a case filed by a former senior executive alleging he was fired because he was not Japanese.

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Medical device makers ink interoperability pledge

January 15, 2013 by MassDevice staff

Nine prominent medical device companies sign on to a pledge to increase the interoperability of their products in the interest of patient safety.

Patient Safety Science & Technology Summit

Nine medical device companies ranging from industry titans to small-cap movers inked a pledge to make the data generated by their devices available to patients, in a move aimed at ridding the healthcare system of unnecessary deaths by 2020.

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Beacon Endoscopic lands partnership with Fujifilm to distribute its Needle eXchange system

January 4, 2013 by MassDevice staff

Beacon Endoscopic partners with Fujifilm to distribute Beacon’s endoscopic ultrasound devices in select markets outside the U.S. 

Beacon Endoscopic logo

Newton, Mass.-based endoscopic startup Beacon Endoscopic signed a strategic partnership in order distribute its 2nd product internationally through Fujifilm Holdings (TSE:4901), the companies announced.

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