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Terumo recalls select Solopath balloon systems

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Terumo (OTC:TRUMY;TYO:4543) is recalling a select number of its Solopath balloon expandable transferal system and re-collapsible balloon access systems due to issues with tip dislodgment from the sheath that could cause possible patient injuries. The FDA has labeled the recall as Class I, its most severe classification which is used when there is a reasonable probability […]

Terumo’s Microvention touts Web aneurysm embolization study

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Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention today released results from the WEB-IT pivotal trial of its Web aneurysm embolization system. Results from the trial were published in the online edition of the Journal of NeuroInterventional Surgery, the Aliso Viejo, Calif.-based company said. The trial enrolled a total of 150 patients across 21 U.S. centers and six international centers, MicroVention said. […]

Terumo’s MicroVention wins FDA approval for Web brain aneurysm device

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Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for the Web brain aneurysm device it acquired when it bought Sequent Medical back in 2016. Aliso Viejo, Calif.-based MicroVention said the PMA for the Web embolic coil covers the treatment of intracranial wide neck bifurcation aneurysms. “We are proud to offer […]

InspireMD touts results of next-gen stroke prevention stent study

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InspireMD (NYSE:NSPR) has released the results of a meta-analysis of four clinical studies involving dual-layered (DLS) and mesh-covered stents, including the company’s MicroNet-covered stent, the CGuard embolic prevention system. The analysis concluded that carotid artery disease patients treated with mesh-covered stents experienced a 30-day minor stroke rate of 1.25%, lower than the 30-day minor stroke rates reported in […]

The 10 largest medtech employers of 2018 – and what their employees really think

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Among the 10 largest medtech employers, workers feel pride in working on life-saving products – but there’s also frustration with big corporate bureaucracy. That was the major takeaway as Medical Design & Outsourcing compiled some of the most insightful current and former employee reviews posted on Glassdoor. The 10 companies we’re counting down were the largest […]

ivWatch to integrate IV infiltration sensor into Philips’ patient monitors

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For decades, nurses have sent drugs surging through a patient’s body using the power of the circulatory system. Catheters deliver medications destined to travel through a person’s veins – but it doesn’t always turn out that way. Sometimes, leaky veins cause drugs to seep into surrounding tissue or to back out of the insertion site, […]

Terumo’s MicroVention wins expanded FDA indications for Sofia cath

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Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today it won FDA clearance for a new clinical indication for its Sofia catheter designed for intracranial access, now cleared for contact aspiration procedures to treat acute ischemic stroke. The company said it won CE Mark approval in the European Union for the aspiration in 2015, and that the device has been used […]

Terumo’s Vascutek, Bolton Medical merge to form Terumo Aortic

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Terumo Corp. (TYO:4543) said today its Vascutek subsidiary and Bolton Medical have merged together to form a new company, Terumo Aortic. The newly combined company is expected to have a revenue of more than $200 million, and will employ more than 1,100 individuals worldwide, Tokyo-based Terumo said. Terumo Aortic will look to accelerate its position in treating aortic […]

Terumo pays at least $20m for Medeon Biodesign’s XPro vascular closure device

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Medeon Biodesign (TPEx:6499) said today that it agreed to sell its XPro suture-mediated vascular closure device to Terumo Corp. (TYO:4543) for $20 million up front, plus milestones. The XPro device is designed for vascular closure following transcatheter aortic valve replacement, endovascular aneurysm repair, thoracic endovascular aneurysm repair and percutaneous balloon aortic valvuloplasty procedures. Medeon said it plans […]

7 medtech stories we missed this week: Sept. 29, 2017

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From EOI getting FDA clearance to Sanuwave’s new joint venture agreement, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. EOI wins FDA nod for FLXfit15 expandable cage EOI announced in a Sept. 28 press release that it has received FDA 510(k) clearance for its FLXfit 15. The clearance […]

GE Healthcare CEO Flannery promoted to GE’s corner office | Personnel Moves – June 12, 2017

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Former GE Healthcare (NYSE:GE) head John Flannery will be stepping into the corner office for all of GE, replacing Jeff Immelt who is stepping aside after 16 years as head of the large conglomerate. The CEO transition will go into effect Aug. 1, while Flannery will also take over as board chair after Immelt retires on […]

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