Fujifilm Holdings (TSE:4901) said its Fujifilm Medical Systems U.S.A. subsidiary lured an Accuray (NSDQ:ARAY) executive and a physician from the University of Southern California to its executive roster effective Sept. 28. The Stamford, Conn.-based company said Johann Fernando, formerly Accuray’s vice president & general manager, was named to be its operations chief. Dr. Diku Mandavia, who has […]
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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 […]
Fujifilm SonoSite wins CE Mark for iViz mobile ultrasound
Fujifilm (TSE:4901) said its SonoSite subsidiary won CE Mark approval in the European Union for its iViz handheld mobile ultrasound device. The device is a next-generation hand-held platform for ultrasound, operated through a high-resolution 7-inch touchscreen. The device features Wi-Fi and bluetooth connectivity and access ports for USB, HDMI and audio, according to the Bothell, Wash.-based […]
Fujifilm Submits 1st PMA module for digital breast tomosynthesis
Fujifilm Medical Systems (TSE:4901) said today it submitted the 1st module of its FDA premarket approval application for digital breast tomosynthesis as an upgrade for its Aspire Cristalle mammography system. The module is the 1st to be submitted for FDA PMA modular review with plans to submit the remaining modules within the coming year, Stamford, Conn.-based […]
NuVasive shuffles the deck | Personnel Moves
NuVasive Inc. (NSDQ:NUVA) announced a flurry of new executive assignments yesterday as it reorganizes its leadership team under new CEO Gregory Lucier, who took over the position in May from ousted Alex Lukianov. NuVasive 14-year vet Pat Miles will stay on as COO and president, a position he was appointed to earlier this year, NuVasive said. […]
Justice expands endoscope ‘superbug’ probe
(Reuters) — The U.S. Justice Dept. subpoenaed 2 more manufacturers of medical scopes linked to deadly “superbug” outbreaks in recent weeks, USA Today reported, citing 2 sources familiar with the investigation. Last week, reports revealed 1 duodenoscope manufacturer, Olympus (TYO:7733), was being investigated by the federal agency, but the broader reach of the investigation, including subpoenas to other makers Fujifilm Holdings (TSE:4901) […]