Pentax Medical announced today that it earned FDA 510(k) clearance for new models of its i20c video endoscope series. The new models — the Video Colonoscope EC34-i20cL, Video Upper GI Scope EG27‑i20c and Right/Left Wheel Extender OE-B17 — work in combination with the Pentax Medical Inspira Video Processor EPK-i8020c. They support healthcare professionals in detection, diagnosis […]
Pentax
Pentax wins FDA nod for duodenoscope with new sterilization tech
Pentax Medical announced today that the FDA cleared its DEC duodenoscope compatibility with the Sterrad 100NX sterilizer. Advanced Sterilization Products (ASP) develops Sterrad as its flagship product. Together, the companies aim to address the ongoing challenges of duodenoscope reprocessing. They hope to reduce the risk of cross-contamination with the scopes, enabling easier access to sterilized […]
5 innovations to make duodenoscopes more single-use — and save lives
Duodenoscopes are important medical devices that are used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, the devices have had serious problems in the past. Luckily, several medical device companies have stepped in to solve the problems. (Here are five of the innovations.) Duodenoscopes are flexible, lighted tubes threaded through the mouth, throat and stomach into the […]
Pentax launches high-def bronchoscopes in U.S.
Pentax Medical announced today that it launched its EB-J10 Series bronchoscopes in the U.S. after receiving FDA 510(k) clearance. The Hoya (TYO:7741) subsidiary’s EB-J10 Series bronchoscopes are designed to provide high-definition visualization of the bronchus and have compatibility with the simultaneously launched Defina video processor for supporting pulmonology practices with advanced imaging. Montvale, N.J.-based Pentax’s EB-J10 […]
Pentax Medical launches Imagina endoscope in U.S.
Hoya (TYO:7741) subsidiary Pentax Medical announced that it won FDA 510(k) clearance for its Imagina endoscopy system and initiated the device’s U.S. launch. The Imagina system is designed to perform gastrointestinal (GI) procedures at ambulatory surgery centers (ASCs). It features a touch-screen LCD interface while eliminating the need for periodic bulb replacements. It also includes the […]
Pentax has a duodenoscope meant to reduce superbug fears — and now it’s for sale in the U.S.
Hoya (TYO:7741) subsidiary Pentax Medical has announced the U.S. launch of its DEC HD duodenoscope, which boasts a sterile, disposable elevator meant to reduce reprocessing challenges associated with the device. The news, released yesterday, comes about a week after FDA announced clearance of the Pentax duodenoscope. The DEC HD duodenoscope has been available in global […]
BREAKING: FDA clears Pentax Medical duodenoscope meant to reduce superbug fears
The FDA today announced that it has cleared a duodenoscope from Hoya’s (TYO:7741) Pentax subsidiary that has a sterile, disposable elevator — a first in the U.S. The Pentax Medical duodenoscope’s design reduces the number of parts requiring cleaning and disinfection between uses, according to the FDA. Reducing reprocessing challenges, the thinking goes, will help prevent […]
FDA pushes duodenscope makers, users away from reprocessed devices
The FDA yesterday recommended that healthcare providers move away from a type of infection-prone duodenoscope in favor of devices that can better be sterilized, after post-market surveillance again found higher-than-expected contamination rates of “high-concern organisms.” In April the FDA revealed new data showing that rates of so-called “superbug” infections were nearly twice as high as […]
Sen. Murray goes after duodenoscope makers
Senator Patty Murray (D-Wa) is going after duodenoscope makers again over continued concerns about high rates of contamination in the devices, even after sterilization and cleaning, according to letters the official sent to makers Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary. The letter comes only a month after the FDA released an analysis of medical device reports […]
FDA: Duodenoscope reprocessing is dirtier than we thought
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 […]
7 medtech stories we missed this week: August 3, 2018
From Esaote launching its new ultrasound device to Nipro’s Infraredx launching in Japan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Esaote launches new ultrasound devices Esaote announced in an Aug. 2 press release that it has launched its new MyLab X7, MyLab X6 and MyLab X5 ultrasound […]
