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FDA reinstates clearance process for Iradimed’s MR-safe MRidium 3860 infusion...
Iradimed (NSDQ:IRMD) said it doesn’t need to perform any more human factors usability testing to get its bid for 510(k) clearance past the FDA for the MRidium 3860+ MRI-safe IV infusion pump. The FDA...
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Study: Lower major complication risk with Medtronic’s Micra compared to...
Medtronic (NYSE:MDT) today released new results from a clinical trial of its leadless Micra transcatheter pacing system, touting significantly reduced major complication risks compared to conventional...
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Ascensia Diabetes reups development deal with Medtronic
Asensia Diabetes Care said today it renewed a diabetes management development partnership with Medtronic (NYSE:MDT), through which Ascensia will retain exclusive rights to co-develop and supply Contour...
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Insulet updates on artificial pancreas, pipeline products
Insulet (NSDQ:PODD) said today it will present new clinical data on its artificial pancreas algorithm, new product pipeline and evidence from studies of its OmniPod system. The news is set to be...
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NeuroMetrix closes $21.3m funding round
NeuroMetrix (NSDQ:NURO) said yesterday it closed a $21.3 million round of funding through the private placement of preferred stock and warrants to support its Quell wearable pain relief device for...
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MassDevice.com +5 | The top 5 medtech stories for June 9, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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Diasend, Abbott ink diabetes data management pact
Diasend said today it inked a cloud-to-cloud deal with Abbott (NYSE:ABT) to connect its LibreLink system to Diasend’s diabetes data management system. Through the deal, users of Abbott’s FreeStyle...
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NuVasive co-founder McKinley is Vascular Dynamics new COO | Personnel Moves...
NuVasive co-founder McKinley is Vascular Dynamics new COO Vascular Dynamics said it tapped NuVasive Inc. (NSDQ:NUVA) co-founder and former CEO James McKinley as its new chief operating officer....
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Struggling GlaxoSmithKline bets big on neural implants to fuel turnaround
GlaxoSmithKline‘s (NYSE:GSK) interest in tiny neural implants is stronger than ever, even amid declining earnings and flopped drug candidates that have turned CEO Andrew Witty into a lame duck who will...
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Eurasian governments issue new harmonized medical device regulations
By Stewart Eisenhart, Emergo Group Governments of five Eurasian countries have issued final regulations to establish a harmonized regulatory system for medical devices and IVDs across their respective...
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Tax court hands Medtronic a win in $1.4B IRS case
A federal judge yesterday found for Medtronic (NYSE:MDT) in its lawsuit against the IRS over a $1.36 billion tax bill. The dispute involves “transfer pricing” among the company’s various units during...
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NuVasive’s $28m loss to distributor in sales poaching case stands
A federal judge in California rejected a bid by NuVasive (NSDQ:NUVA) to overturn its $28 million loss in a sales poaching lawsuit with 1 of its distributors. Earlier this year a jury in the U.S....
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Medtronic touts shorter stays, less retreats with cryoablation for treating...
Medtronic (NYSE:MDT) today touted data from its Fire and Ice clinical trial indicating lower rates of repeat procedures and shorter hospital stays for patients with paroxysmal atrial fibrillation...
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FDA’s device evaluation program is underway
The Food and Drug Administration (FDA) has been working closely with Industry negotiators and other stakeholders for years to establish a National Evaluation System for medical devices. The goal of...
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Ethicon mesh plaintiffs claim company expert admitted mesh degrades
Plaintiffs in the multi-district litigation brought over the pelvic mesh made by Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon claimed this week that a company expert admitted that Ethicon knew...
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FDA lifts shipping restrictions on Terumo’s Michigan plant
Terumo Corp. (TYO:4543) said today it received a notice from the FDA lifting all shipping restrictions at its Ann Arbor, Mich. facility that were imposed in 2011 as part of the company’s consent...
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MassDevice.com +5 | The top 5 medtech stories for June 10, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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Study backs laser prostate ablation with Medtronic’s Artemis
Laser ablation may be a feasible and safe treatment option for men with intermediate risk prostate cancer, according to a new study published in the Journal of Urology. The treatment operates using...
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Innovatex wins down-classification for tear duct occluder from FDA
The FDA said today it granted Innovatex Class I classification for its Tear Duct Occluder nasolacrimal compression device. The Tear Duct Occluder device is a designed to apply mechanical pressure to...
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BioTime subsidiary wins $2m grant for regenerative dry-AMD treatment
Regenerative medicine company BioTime said today its subsidiary Cell Cure Neurosciences won a $2.2 million (ILS ₪8.4 million) grant from the Israel Innovation Authority of the Ministry of Economy and...
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