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 […]
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 […]
Olympus and FlexDex take aim at big, expensive robots
Olympus has signed an agreement with FlexDex Surgical to compete with full-blown robotics systems designed for minimally invasive procedures, the companies said today. Olympus agreed to distribute FlexDex’s (Brighton, Mich.) wrist-worn Needle Driver robotic device designed to simplify suturing in difficult-to-reach areas of the abdomen. Needle Driver has a three-axis gimbal that attaches to the surgeon’s wrist to control […]
ViewRay picks up ex-Spectranetics CEO Drake, COO Matin | Personnel Moves – July 25, 2018
ViewRay (NSDQ:VRAY) said yesterday it tapped former Spectranetics head Scott Drake as its new chief executive officer and former Spectranetics COO Shar Matin as its new COO. Before joining ViewRay, Drake served as CEO and prez of Spectranetics, which was acquired by Royal Philips (NYSE:PHG) in a deal that closed last August. Drake also serves as board chair […]
Olympus partners with MedTech Innovator accelerator
Olympus (TYO:7733) said yesterday it is partnering with accelerator MedTech Innovator. As part of the partnership, Tokyo-based Olympus will provide financial support to MedTech Innovator, and will work with the incubator to select companies that will be part of its program. “At MedTech Innovator, we have a proven track record of identifying the most promising medical technology […]
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