Category: Endoscopic / Arthroscopic
Endoscopic / Arthroscopic
Boston Scientific says the FDA cleared the SpyGlass DS version of its cholangioscopy and pancreatoscopy device.
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.
The FDA warns ERCP endoscopes may allow for the transmission of certain drug-resistant "superbugs," even if the devices are properly cleaned.
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.
Regulators have known since at least 2009 that the medical devices at the center of the "superbug" outbreak at UCLA
(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 closes $20 million in new funding as it gear up to commercialize its robot-assisted flexible endoscope in Europe.
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 voluntarily recalls power morcellators used in fibroid surgeries on the risk that they may unintentionally spread cancer.
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.
Cantel Medical says it's agreed to pay nearly $27 million for British 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.