FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies. Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially higher-than-expected risk of blood […]
Terumo
Terumo to acquire Health Outcomes Sciences
Terumo (TSE: 4543) recently announced that it has signed a definitive agreement to acquire all assets of Health Outcomes Sciences. The financial terms of the deal were not disclosed. Phoenix-based HOS is a creator of predictive analytics and clinical decision support software. Its sePRISM content enablement platform is meant to enable healthcare organizations to deliver […]
FDA approves low-profile aneurysm embolization system
Terumo (TYO:4543) subsidiary MicroVention announced today that it received FDA approval of a PMA supplement for its WEB 17 system. Aliso Viejo, Calif.-based MicroVention’s WEB 17 system is a new addition to its WEB aneurysm embolization system for treating intracranial wide-neck bifurcation aneurysms, according to a news release. WEB 17 features a lower profile delivery system compatible […]
MicroVention suing Balt
Terumo (TYO:4543) subsidiary MicroVention announced today that it filed a second lawsuit against Balt USA for trade secret misappropriation. Aliso Viejo, Calif.-based MicroVention’s second lawsuit against Balt and four former employees follows an earlier patent lawsuit that is still ongoing, having been filed in July 2019, according to a news release. MicroVention alleges that, during the discovery […]
How did medtech companies score on environmental stewardship list?
Medical Design & Outsourcing recently rated the world’s largest medical device companies — the Big 100 — for their sales numbers and R&D spend. Now we can share how some of them scored on an environmental nonprofit’s annual list of companies ranked for their actions on climate change. Not-for-profit organization CDP (Stockholm, Sweden) runs a global disclosure system for […]
MedTech 100 roundup: Industry hits pandemic peak
After five months since medtech stocks peaked before the COVID-19 pandemic rocked the markets, the industry inched back toward that pre-pandemic high. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 88.9 points at the end of last week (July 17). That total represents just a -3.7% […]
Terumo acquires Quirem Medical for up to $45m
Terumo (OTC:TRUMY;TYO:4543) announced this week that it has completed the acquisition of Netherlands-based startup Quirem Medical, which is developing microspheres for selective internal radiation therapy (SIRT), a treatment for liver tumors. Under the terms of the agreement, Terumo acquired 80.1% of the shares of Quirem Medical. This is over and above its current share position of 19.9%, […]
Fibralign partners with Terumo
Stanford spin-out Fibralign announced today that it entered into a long-term distributor agreement with Terumo for the BioBridge collagen matrix. The agreement is set to see Terumo market and distribute BioBridge collagen matrix, which is used to treat and prevent secondary lymphedema, in Japan. BioBridge is a sterile, implantable, biocompatible and biodegradable surgical mesh made […]
Terumo Aortic gains FDA breakthrough designation for aortic arch repair device
Terumo Aortic this week said it received FDA breakthrough device designation for its Thoraflex Hybrid stented device for complex aortic arch repair. Thoraflex Hybrid is a single-use device that combines a gelatin-sealed woven polyester graft with a Nitinol self-expanding stent graft. It is designed for the surgical repair or replacement of damaged or diseased aortic […]
Terumo, Marker Therapeutics win emergency nod for blood-treatment system
The FDA has issued emergency use authorization (EUA) to Terumo BCT (OTC:TRUMY;TYO:4543) and Marker Therapeutics for a blood purification and oxygenation system to treat patients with COVID-19. Lakewood, Colo.-based Terumo’s Spectra Optia apheresis system works with the Depuro D2000 adsorption cartridges made by Marker Therapeutics to reduce the number of cytokines and other inflammatory blood […]
Stent makers point to quality-of-life findings by massive federal study
The giant federal study that found the use of stents in stable heart-disease patients is no better than drugs to treat clogged arteries reached another, less-hyped conclusion. Manufacturers of stents for percutaneous coronary intervention (PCI) note that the Ischemia study also concluded that patients who undergo a stenting procedure have a better quality of life. They suffer […]
