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 […]
Olympus rejiggers medical biz
Olympus (TYO:7733) last week announced its plan to rejigger its medical device business with an eye toward gaining share in the U.S. market. The Japanese conglomerate weathered an accounting scandal in 2011 after firing its first foreign CEO, Michael Woodford, after he blew the whistle on unexplained payments worth around $1.7 billion and demanded the resignation of the former […]
Olympus fined $85 million in duodenoscope case; former exec faces prison
Olympus (TYO:7733) and a former senior executive in Japan have pleaded guilty in Newark, N.J., to failing to file required adverse event reports involving infections connected to duodenoscopes, and to continuing to sell the devices in the United States despite those failures, the Justice Department announced. Tokyo-based Olympus and Hisao Yabe, 62, both entered guilty pleas before U.S. […]
Olympus wins FDA nod for Spiration bronchial valve
Olympus (TYO:7733) said yesterday that it won FDA approval for its Spiration Valve System intended to treat severe emphysema, which was designated as a breakthrough medical device. The Spiration Valve is an umbrella shaped device intended to improve breathing by blocking airflow to diseased portions of the lung, the Tokyo-based company said. The device is placed during […]
Olympus launches Endoeye Flex 3D, FlexDex needle driver in US
Olympus (TYO:7733) said yesterday it launched the Endoeye Flex 3D and FlexDex needle driver laparoscopic surgical tools in the U.S. The company said that it is the exclusive distributor for FlexDex in the US, and is combining the Endoeye Flex 3D tech with FlexDex’s wristed needle-driver to improve minimal access surgery procedures. The device can be used […]
FDA clears Olympus’ latest biopsy needle
Olympus said it has won FDA clearance for its EZ Shot Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product line for both fine needle aspiration (FNA) and fine needle biopsy (FNB). The approvals “can drive improved staging of disease and the potential to more easily connect patients […]
- 1
- 2
- 3
- …
- 12
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube