Category: Endoscopic / ArthroscopicSyndicate content

Endoscopic / Arthroscopic

FDA clears new version of Boston Scientific's SpyGlass

February 26, 2015 by Brad Perriello

Boston Scientific says the FDA cleared the SpyGlass DS version of its cholangioscopy and pancreatoscopy device.

FDA clears new version of Boston Scientific's SpyGlass

Boston Scientific (NYSE:BSX) said the FDA granted 510(k) clearance for the latest iteration in its line of cholangioscopy and pancreatoscopy devices, the SpyGlass DS.

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.

Medrobotics taps backers for $20m

October 21, 2014 by Alexander Soule

Medrobotics closes $20 million in new funding as it gear up to commercialize its robot-assisted flexible endoscope in Europe.

Medrobotics taps markets for $20m

Medrobotics said it closed on $20 million in new funding in a preferred stock sale to prior backers as plans to expand its commercial footprint in Europe.

Raynham, Mass.-based Medrobotics also said that it's "met all applicable FDA requirements" to distribute its Flex Retractor in the U.S.

Johnson & Johnson recalls power morcellators over cancer risk

July 31, 2014 by Brad Perriello

Johnson & Johnson voluntarily recalls power morcellators used in fibroid surgeries on the risk that they may unintentionally spread cancer.

Johnson & Johnson recalls power morcellators over cancer risk

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Steris, Medtrica win legal fees in Cygnus Medical patent spat

July 15, 2014 by Brad Perriello

A federal judge agrees to award legal fees to Steris and Medtrica in their patent infringement win over Cygnus Medical, after a U.S. Supreme court decision reboots the rules on awarding legal costs.

Steris, Medtrica win legal fees in Cygnus Medical patent spat

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Cantel Medical to pay $27M for endoscope reprocessor PuriCore

June 6, 2014 by Brad Perriello

Cantel Medical says it's agreed to pay nearly $27 million for British endoscope reprocessor PuriCore.

Cantel Medical to pay $27M for endoscope reprocessor PuriCore

Cantel Medical (NYSE:CMN) said it agreed to put up $26.9 million in cash to acquire PuriCore International, a British endoscope reprocessing company.

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