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Perfuze raises $3m seed round for Millipede stroke catheter
Perfuze said today that it raised more than $3 million for the Millipede catheter it’s developing to treat ischemic stroke. Although not quite in stealth mode, the Galway, Ireland-based firm is close-mouthed about its technology. CEO Wayne Allen and CTO Liam Mullins (who co-founded Embo Medical before its  in 2015,  $YY acquisition by C.R. Bard in 2015) founded Perfuze last year. The €3 million ($3.4 million) seed round, earmarked for Millipede development, was led by European VC shop Earlybird. MedFocus, Enterprise Ireland and an Irish syndicate of medtech veterans and stroke physicians also participated, Pe...
Source: Mass Device - January 29, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Featured Funding Roundup Neurological Perfuze Stroke Source Type: news

Cerenovus Receives FDA Nod for EMBOTRAP II
Johnson & Johnson’s Cerenovus unit has received an FDA nod to market the EMBOTRAP II Revascularization Device. The device is a next generation stent retriever used to capture and remove life-threatening blood clots from the brain following an ischemic stroke. The EMBOTRAP II Device is designed to rapidly restore blood flow by gripping and retrieving clots within the neurovasculature, with minimal compression, protecting against further complications. The device is indicated for use within eight hours of stroke symptom onset. In the ARISE II study, which was submitted as part of the 510(k) application to FDA, neuroint...
Source: MDDI - May 21, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Past Covidien, ev3 Activities are Costing Medtronic a Hefty Sum
Sometimes acquiring other companies means taking the bad with the good. In Medtronic's case, that means settling multiple Department of Justice claims against ev3, a business Medtronic owns by way of its Covidien acquisition. Covidien bought ev3 in 2010 and Medtronic finalized its $49.9 billion Covidien deal in early 2015. Now, Medtronic is paying the price for activities that ev3 allegedly conducted between 2005 and 2009 involving the Onyx Liquid Embolic System. FDA approved the device in 2005 as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations ...
Source: MDDI - December 5, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Medtronic, Germany’s Phenox to open new plants in Ireland
Medtronic (NYSE:MDT) and German medical device maker Phenox are each planning to open new manufacturing plants in Galway, Ireland. Fridley, Minn.-based Medtronic said it plans to spend about $14.3 million (€13 million) building a new, 20,000-square-foot facility will be used to make its In.Pact Admiral drug-coated balloon. The plant is expected to employ about 100 workers, the company said. “Since launching the In.Pact Admiral DCB in the U.S. market, it has quickly become the fastest adopted DCB technology. In fact, our global market leadership in DCB is driving the need to open the new facility here in Galway to...
Source: Mass Device - December 14, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Business/Financial News Medtronic phenox Source Type: news

FDA approves Malin ’ s Hourglass peripheral embolization plug
Irish life sciences company Malin Corp said today it won FDA 510(k) clearance for its Hourglass peripheral embolization plug. The company said the Hourglass plug is designed to be deployed over-the-wire for peripheral embolization procedures, and can provide immediate occlusion with a single integrated device. “This is the 1st integrated, over-the-wire device designed for peripheral embolization procedures. The goal with over-the-wire design is to provide physicians with accurate, stent-like delivery of the device in the vessel,” Hourglass co-developer George Wallace, said in prepared remarks. “The Hourgl...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Regulatory/Compliance Vascular malincorp Source Type: news

The Grass Is Green for Medtech on the Emerald Isle
You don’t have to be a medtech veteran to have heard of Ireland’s ties to the industry. Still, even those who have spent years working in medical devices and diagnostics may be surprised to learn that 14 of the top 15 global medtech companies—including Boston Scientific, DePuy Synthes, Medtronic, Teleflex, and many more—have facilities in Ireland. Why Ireland? Just what is drawing medtech to Ireland? The country has gained recognition as a frequent target for corporate inversion deals that enable companies to fall under more favorable corporate tax rates, but a 12.5% tax rate is just part of what brings medtech com...
Source: MDDI - November 14, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Medical Device Business Source Type: news

Medtronic Finds Another Value-Based Care Partner
Dublin, Ireland-based Medtronic continues to lead the charge toward value-based care with a new five-year strategic partnership with Lehigh Valley Health Network (LVHN), an eight-hospital network in Northeastern Pennsylvania. The partnership is aimed at developing innovative, sustainable, and integrated value-based solutions to improve healthcare outcomes for LVHN's patients. The partnership will create programs that span more than 70 major medical conditions, with the goal of positively impacting as many as 500,000 patients and reducing their cost of care by $100 million.  The organizations said the partnership will leve...
Source: MDDI - February 28, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

Edwards launches US pivotal Centera self-expanding TAVR study
Edwards Lifesciences (NYSE:EW) said yesterday it launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Edwards said. The Irvine, Calif.-based company said it hopes to enroll approximately 1,000 patients in the trial, which will include a bicuspid registry. The endpoint fo...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news

Report: Boston Scientific looks to lure Irish expats from Australia to fill its roster
In an effort to fill open positions at its Galway, Ireland-based facilities, Boston Scientific (NYSE:BSX) is offering to cover relocation costs for expatriated residents that left for positions in Australia, according to a Connacht Tribune report. The residents left Galway for Australia during the recent recession, according to the report, leaving a shortage of skilled workers in Ireland. Due to the shortage, the Marlborough, Mass.-based company has begun head hunting in Australia, looking for senior quality and manufacturing engineers and to fill R&D roles, according to the Connacht Tribune. Boston Scientific is look...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Boston Scientific Source Type: news