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 […]
Fujifilm
Biogen to sell Denmark-based manufacturing site to FujiFilm for $890m
Biogen (NSDQ:BIIB) said yesterday that it inked an $890 million deal to sell a Denmark-based manufacturing site to Fujifilm (TSE:4901). The site, located in Hillerød, includes a biologics production facility with assembly, labeling and packing capabilities as well as quality control laboratories and warehouses, Cambridge, Mass.-based Biogen said. The facility also has approximately 800 employees who are […]
ASTRO 2018 Roundup: Fujifilm enters US CT market with FCT Embrace
Fujifilm (TSE:4901) said this week it launched the FCT Embrace 85cm wide bore computed tomography imaging unit, touting it as the world’s first such device to hit the market. The system launch marks the company’s first foray into the CT field, FujiFilm said. The release was announced at the American Society for Radiation Oncology annual meeting […]
EU approves fifth biosimilar for blockbuster Humira drug
Mylan (NSDQ:MYL) and Fujifilm Kyowa Kirin Biologics said today that the European Commission gave the companies marketing authorization for Hulio, a biosimilar to AbbVie‘s (NYSE:ABBV) billion-dollar Humira product. Mylan said it plans to launch Hulio across particular markets in Europe on or after Oct. 16. The drug is the fifth product authorized by the EC as a biosimilar for […]
Fujifilm Sonosite taps Ueda as chair, CEO | Personnel Moves – August 9, 2018
Fujifilm‘s (TSE:4901) SonoSite subsidiary said earlier this week it appointed Fujifilm vet and current Fujifilm Medical Systems USA and Fujifilm New Development USA prez Takaaki Ueda as its new chair and CEO. Previously, Ueda has also served as Fujifilm global endoscopy systems division GM, the company said. Ueda will replace the departing Masayuki Higuchi who […]
FDA issues warning letters to Olympus, Fujifilm, Pentax over duodenoscope issues
The FDA said today it issued warning letters to Olympus (TYO:7733), Fujifilm Holdings (TSE:4901), and Hoya‘s Pentax Medical over failures to comply with federal orders to conduct postmarket surveillance studies to assess the effectiveness of reprocessing duodenoscopes. The order, issued by the federal watchdog in 2015, required all three manufacturers to conduct postmarket surveillance studies to determine whether healthcare […]
Fujifilm levels mammography patent infringement, anti-trust claims against Hologic
Fujifilm Holdings (TSE:4901) last week accused mammography rival Hologic (NSDQ:HOLX) of patent infringement and unfair trade practices, alleging that Hologic aimed to unlawfully maintain its 80% share in the 3D mammography market. The Japanese tech firm claims in the suit that its Aspire Cristalle system, which sells for roughly half the average $452,000 price of Hologic’s competing […]
Fujifilm wins $768m DoD contract for digital imaging systems, services
UDPATED August 24, 2016, with details from Fujifilm. Fujifilm Medical Systems won a $768 million fixed-price contract with the U.S. Defense Dept. for its Synapse portfolio of enterprise imaging technologies. The economic-price-adjustment, indefinite delivery, indefinite-quantity contract was a competitive acquisition, with a total of 8 companies submitting bids, according to the Pentagon. The contract spans 5 […]
Fujifilm announces U.S. customer wins for Synapse imaging system
Fujifilm Medical Systems U.S.A. said today that seven U.S. healthcare systems are picking up various products from the company’s Synapse enterprise imaging portfolio. The health systems includeHackensack Meridian Health and West Virginia University Health System – two of the largest healthcare networks in the mid-Atlantic region. Products bought include the Synapse 5 PACS, Synapse VNA, Synapse […]
7 medtech stories we missed this week: August 4, 2017
From MDCorp inking a European distribution deal to Align Technology’s North Carolina expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. MDCorp inks distribution deal with Smart Endoscope Systems MDCorp announced in a July 31 press release that it has signed a distribution agreement with Smart Endoscope […]
FDA clears updated labeling, design for FujiFilm ED-530XT duodenoscopes
Fujifilm Medical (TSE:4901) today issued a select voluntary recall for its model ED-530XT duodenoscopes after the FDA cleared an update to the design and labeling of the device, intending to supply customers with new forceps elevator mechanism from Platform Lift, O-ring seals, distal end caps and updated operations manuals. The company said it won FDA clearance […]