The FDA today ordered a trio of Japanese duodenoscope makers to run post-market surveillance studies to evaluate how the devices are reprocessed in real-world conditions, after a deadly rash of so-called “superbug” outbreaks this year were linked to the devices. The string of deadly infections were attributed to duodenoscopes made by Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya‘s (TYO:7741) Pentax subsidiary. The devices are used for […]
Hoya (TYO:7741) subsidiary Pentax Medical said it agreed to buy a stake in U.K. electrosurgery device maker Creo Medical for an unspecified amount. The move is part of Pentax Medical’s plan to get into the endoscopic therapy device market, the Japan-based company said. “We are pleased to be investing in an organization with a proven record of […]
The family of a Renate Winkler, who died due to a “superbug” infection transmitted by a duodenoscope, said Tuesday they are suing both the treating hospital and Pentax Medical, who manufactured the scope, for wrongful death. Winkler died from a carbapenem-resistent enterobacteriacea infection, which is highly resistant to antibiotics, following an endoscopic retrograde choloangiopancreatography procedure at […]
(Reuters) — The U.S. Justice Dept. subpoenaed 2 more manufacturers of medical scopes linked to deadly “superbug” outbreaks in recent weeks, USA Today reported, citing 2 sources familiar with the investigation. Last week, reports revealed 1 duodenoscope manufacturer, Olympus (TYO:7733), was being investigated by the federal agency, but the broader reach of the investigation, including subpoenas to other makers Fujifilm Holdings (TSE:4901) […]
ConvaTec, which is rumored to be exploring a sale, said yesterday that it made its interim CEO, former EMEA president Paul Moraviec, to be its new permanent CEO.
Luxembourg-based ConvaTec, which is owned by private equity firms Avista Capital Partners and Nordic Capital, tapped Moraviec to lead its business in Europe, the Middle East and Africa in 2009.