The FDA said today that new data show that the contamination rate for “high-concern organisms” in duodenoscopes is nearly twice as high as previously thought and warned the devices three major manufacturers to get their required post-market studies in gear. Back in 2015 the federal safety watchdog warned Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary following a string […]
FDA OKs limited duodenoscope sterilization by Custom Ultrasonics AERs
The FDA today announced that Custom Ultrasonics completed validation testing of its System Plus automated endoscope reprocessors, and that the devices are cleared for the reprocessing of certain duodenoscopes. With the clearance, the Philadelphia-based company’s line of System 83 Plus AERs are cleared for washing and disinfecting the Olympus (TYO:7733) TJF-180V and Pentax ED-3490TK duodenoscopes, according to an FDA […]
Pentax Medical, Aohua ink JV endoscopy deal
Hoya‘s Pentax Medical said today it inked a joint venture deal with Shanghai Aohua Photoelectricity to develop flexible medical endoscopy products. The new JV company will look to offer endoscopy solutions with an initial focus on “needs of emerging markets,” according to Tokyo-based Pentax. “With Pentax Medical as our partner, this joint venture provides Aohua […]
FDA warns again on Pentax duodenoscopes
The FDA issued a statement today warning that Hoya (TYO:7741) subsidiary Pentax Medical’s ED-3490TK video duodenoscopes have a potential risk associated with the design and manufacturing of the device. Cracks in the adhesive that seals the scope’s distal cap and tip can lead to microbial and fluid ingress, according to information provided to the FDA by Pentax. […]
Report: CVRx CEO Yared tapped for AdvaMed chairman | Personnel Moves for June 27, 2016
Report: CVRx CEO Yared tapped to succeed BD’s Forlenza as AdvaMed chairman Nadim Yared, the CEO of CVRx, is reportedly slated to replace Becton Dickinson (NYSE:BDX) chief executive Vincent Forlenza as chairman of AdvaMed, the medical device industry’s national lobby in Washington. It’s the 1st time the Advanced Medical Technology Assn. will have a small company’s […]
Pentax Medical picks up controlling stake in Simmedica
Hoya (TYO:7741) subsidiary Pentax Medical said today it acquired over 90% of the shares in Spanish and Portugeuese endoscopy and surgery product and service company Simmedica. Pentax Medical said it made the decision to acquire a majority ownership in the company based upon an increase in sales volume and service over the recent years. “I am delighted that […]
Pentax updates on FDA-cleared scope labeling to fight “superbugs”
The FDA said it cleared updated reprocessing instructions for Pentax’s ED-3490TK video duodenoscopes to avoid infectious outbreaks of “superbugs.” Duodenoscopes are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More than 500,000 ERCPs using the devices are performed in the U.S. […]
Senate report faults hospitals, device makers, FDA for deadly ‘superbug’ outbreaks
A report by Democrats on the U.S. Senate’s health committee issued this week blames hospitals, medical device companies and the FDA for the deadly outbreaks of so-called “superbug” infections linked to duodenoscopes. The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of […]
FDA orders ‘scope makers to launch postmarket studies
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’s Pentax Medical buys stake in Creo
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 […]
Superbug victim’s family sues Pentax
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 […]
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