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 […]
Fujifilm
Fujifilm wins DoD nod for Synapse PACS line
Fujifilm Holdings (TSE:4901) subsidiary Fujifilm Medical Systems said today it won an Authority to Operate from the US Department of Defense for its Synapse PACS line, touting it as the 1st such product to receive a risk management framework based ATO. With the clearance, the US DoD has determined that the Synaps PACS line meets its […]
Health Canada approves Fujifilm’s Vevo HD ultra-high-frequency ultrasound device
Fujifilm Sonosite Inc. subsidiary Fujifilm VisualSonics Inc. said today that it won approval from Health Canada for its Vevo Med ultra-high-frequency clinical ultrasound device. The device operates at frequencies that are higher than conventional ultrasound devices, enabling healthcare professionals to see sonograms with image resolution down to 30 micrometers. “Throughout its history, Fujifilm has been […]
Fujifilm pulls older duodenoscopes after superbug outbreaks
Fujifilm Holdings (TSE:4901) said today that it will pull its legacy 250/450 duodenoscope models from clinical use and replace those devices with the ED-530XT model at no cost to its customers. The company said in a letter to its customers that the decision is not directly related to any safety concerns and that it has not received any recent […]
Fuji’s Cellular Dynamics launches retinal disease-focused Opsis Therapeutics
Fujifilm Holdings (TSE:4901) company Cellular Dynamics International said today it is launching Opsis Therapeutics, a new venture aiming to develop treatments for patient suffering from retinal diseases. The newly formed business aims to focus on retinal cell manufacturing and application of regenerative medicines for treating retinal diseases, the company said. CDI made the initial seed investment […]
Fujifilm files last PMA module for Aspire Cristalle breast tomosynthesis software
Fujifilm Holdings (TSE:4901) said yesterday it filed its last Premarket Approval module to the FDA for its Aspire Cristalle breast tomosynthesis optional software upgrade for its Aspire Cristalle digital mammography system. The optional upgrade is known as the Amulet Innovality outside of the U.S., and has been available since May 2013 in the E.U., Asia and […]
Toshiba Medical Systems enters the race for Takeda’s chemicals subsidiary
Toshiba Medical Systems, the medical device business Toshiba (TYO:6502) is selling to Canon (NYSE:CAJ) for $6.5 billion, reportedly entered the race to acquire a chemicals subsidiary of Takeda Pharmaceutical (TYO:4502). The Nikkei business daily reported today that Takeda is looking to sell its 70% stake in Osaka-based Wako Pure Chemicals Industries, with the 1st round of bidding closing August 16. Toshiba Medical is competing […]
Fujifilm wins FDA nod for digital radiography suite
Fujifilm Medical Systems (TSE:4901) said today it won FDA 510(k) for its digital radiography FDR Visionary Suite and FDR Clinica X-ray components. The new Visionary Suite X-ray system is designed for mid-to-large hospitals and health systems, while the FDR Clinica X-ray components were designed for outpatient facilities, FujiFilm said. “We take great pride in our ability […]
Report: Japan OKs Canon’s $6.5B Toshiba Medical buy, despite reservations
Anti-trust regulators in Japan reportedly approved the $6.5 billion acquisition of Toshiba‘s (TYO:6502) medical device business to Canon (NYSE:CAJ), but warned about the deal’s questionable structure. Toshiba managed to book the sale before the deal actually closed by setting up a holding company with just $300 in assets to skirt Japanese anti-trust regulations. Yesterday Japan’s Fair Trade Commission said the method […]
Fujufilm, jilted in Toshiba Medical sale, still hot to trot the M&A trail
Fujifilm Holdings (TSE:4901), which lost out in March to Canon (NYSE:CAJ) in the race for Toshiba‘s (TYO:6502) medical device business, is still hot to trot on the mergers & acquisitions trail. New COO Kenji Sukeno said the Japanese company is looking at pharmaceuticals and the regenerative medicine space. “There are various deals on the table, though I can’t give details,” Kenji […]
Novartis pharma head Epstein steps away, most recent in string of top-level turnovers | Personnel Moves, May 27, 2015
Novartis pharma head Epstein steps away, most recent loss in string of top-level turnovers Novartis (NYSE:NVS) is facing an upheaval in its top management, seeing 7 departures over the last 5 months as shares fell 25% since last July. Last week, Novartis pharmaceuticals head David Epstein quit as his division was split up. Earlier in the month, U.S. […]