Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease. The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release. Get the full story […]
IceCure Medical inks distro deal with Terumo for Japan, Singapore
IceCure Medical said today that it has signed Terumo (OTC:TRUMY;TYO:4543) as the exclusive distributor of its tumor-freezing technology in Japan and Singapore. Terumo will pay IceCure $2 million for the distro rights if IceCure obtains the appropriate regulatory approvals for its ProSense cryoablation device, designed to treat malignant breast tumors without surgery. This will include […]
Report: “Unglamorous” medtech outshines biopharma in 2019
Medtech merger and acquisition deal announcements slowed in the first half of 2019, but the industry got a boost from Verily’s $1 billion round of funding — the largest ever for a medtech firm. The Verily round was twice the size of the biggest-ever VC deal for a biotech company, according to the Vantage Half-Year […]
Terumo recalls select Solopath balloon systems
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
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
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
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
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
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
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
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 […]
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