Olympus (TYO:7733) announced today that it received FDA de Novo classification for its iTind non-surgical device for treating benign prostatic hyperplasia (BPH). Israel-based medical device manufacturer Medi-Tate originally designed the iTind device. Olympus holds the exclusive right to distribute Medi-Tate products in the U.S. through a strategic investment. The iTind is designed as a flexible, three-strut […]
FDA recommends limiting use of power morcellators
The FDA today recommended that laparoscopic power morcellators, which have been implicated in the spread of cancer, be limited to use with certain tissue containment systems and only in premenopausal women under 50 years of age. Power morcellators were used for 20 years to laparoscopically remove benign tumors of the uterus, known as fibroids, by mincing them. […]
FDA clears Olympus duodenoscope with disposable endcap
Olympus (TYO:7733) announced that it won FDA clearance for its TJF-Q190V duodenoscope with a sterile, disposable distal endcap. The new duodenoscopes are designed to improve the cleaning and reprocessing of the device to reduce contamination. The device is a result of the FDA’s call for more duodenoscopes that are disposable. FDA in August 2019 recommended that […]
Sony to deal $760m stake back to Olympus
Sony (TYO:6758) will reportedly sell its 5% stake in Olympus (TYO:7733) back to the company for nearly $760 million. The deal for Sony’s 68.9-million-share stake is worth ¥80.4 billion, or about $756.7 million, Reuters reported. Hedge fund Third Point, run by activist investor Daniel Loeb, had called for Sony to divest its Olympus shares, although a Sony […]
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 […]
Former Olympus exec gets probation for allowing faulty device sales
Olympus’ former top regulatory official has dodged a prison term for failing to file adverse event reports with the FDA regarding infections connected to contaminated duodenoscopes, according to published reports. Hisao Yabe, 64, and Tokyo-based Olympus (TYO:7733) both entered guilty pleas in December in U.S. District Court in Newark, N.J. for failing to file the […]
Olympus inks deal to distro Meditech Endoscopy’s Scope Pro-tech tip protector
Olympus (TYO:7733) said today that it inked a deal with Meditech Endoscopy to act as the exclusive distributor of its Scope Pro-tech endoscopic tip protector device, which won FDA clearance this month. The Scope Pro-tech tip protector is a sterile, cage-like cover designed to protect the distal tip and bending rubber section of endoscopes from impact […]
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 […]
Olympus announces Spiration bronchial valve launch
Olympus’ Spiration bronchial valve for the treatment of severe emphysema is now available on the market, the company (TYO:7733) said today. The announcement came a month after FDA approval of Spiration, which was designated as a breakthrough medical device. Spiration also has regulatory approval in the E.U., Australia and New Zealand. Get the full story on our […]
Olympus inks precision cancer imaging and treatment dev deal with USC
Olympus (TYO:7733) said late last week that it inked a co-development partnership with the University of Southern California looking to advance multiscale research into cancer prevention, diagnosis and treatment through the use of precision medicine. The deal is a first for the university and the company, Olympus said, adding that it hopes that the personalized treatments […]
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