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UPDATE: Levita Magnetics wins de novo FDA clearance for gallbladder surgery...
Updated with comment from Levita Magnetics CEO Alberto Rodriguez-Navarro. Medical device developer Levita Magnetics said it won FDA de novo clearance for its magnetic surgical system with indications...
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Novocure touts data from Optune-paclitaxel combination study
By Sarah Faulkner NovoCure (NSDQ:NVCR) announced yesterday that its ‘tumor treating fields, combined with the drug paclitaxel, are effective against ovarian cancer, the 5th most-common cause of cancer...
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Judge fast-tracks Alere suit against Abbott, urges mediation
A Delaware judge today expedited Alere‘s (NYSE:ALR) lawsuit against Abbott (NYSE:ABT) seeking to force Abbott to adhere to the terms of its $5.8 billion acquisition, but urged the companies to reach an...
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Stryker, Monsanto director Parfet steps down | Personnel Moves, Sept. 2, 2016
Stryker, Monsanto director Parfet steps down Stryker (NYSE:SYK) and Monsanto (NYSE:MON) said this week that board member William Parfet stepped down from their boards, but declined to reveal the reason...
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FDA approves Concentric Medical’s Trevo clot retrievers
The FDA said today it granted expanded approval to 2 Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo clot retrieval devices, with new indications as initial therapy for strokes due to blood...
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Balt International buys Blockade Medical
European medtech firm Balt International said today it acquired endovascular device developer Blockade Medical for an undisclosed amount. The acquisition is part of Balt’s ongoing strategy to bolster...
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PPC Industries sub Kelpac Medical buys Xeridiem Medical
PPC Industries’ Kelpac Medical division said today it acquired Xeridiem Medical Devices for an undisclosed amount. Get the full story at our sister site, Medical Design & Outsourcing. The post PPC...
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Insulet re-ups material deal with Flextronics
Insulet (NSDQ:PODD) said yesterday it extended a materials and manufacturing deal with Flextronics (NSDQ:FLEX) to produce and manufacture its Omnipod insulin management system for an additional 5...
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Stanford launches independent study of Fibralign’s BioBridge
Stanford University has begun enrollment in an investigator-led clinical study of Fibralign‘s BioBridge collagen matrix designed for treating secondary lymphedema, the company said yesterday. The...
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MassDevice.com +5 | The top 5 medtech stories for September 8, 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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Monteris Medical wins FDA IDE nod for another NeuroBlate brain cancer trial
Monteris Medical said today it won FDA investigational device exemption to explore the use of its NeuroBlate system in patients newly diagnosed with glioblastoma multiforme. The NeuroBlate system is...
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Insulet lifts debt offering to $300m
Insulet (NSDQ:PODD) today released pricing for its previously announced debt offering, increasing the principal amount from $250 million to $300 million. Billerica, Mass.-based Insulet, which makes the...
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Avinger inks deal with HealthTrust GPO
Avinger (NSDQ:AVGR) said today it signed an agreement with group purchasing organization HealthTrust for Avinger’s portfolio of peripheral artery disease products. Get the full story at our sister...
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Dexcom logs German reimbursement win
Dexcom Inc. (NSDQ:DXCM) said yesterday it won reimbursement coverage for its continuous glucose monitoring systems through Germany’s Federal Joint Committee. The reimbursement change was approved by...
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Irregular heartbeat may be tied to more than just stroke risk
(Reuters) – Atrial fibrillation, a type of irregular heartbeat that’s already linked to an increased risk of stroke, may also be tied to higher risk of heart attack, heart failure, kidney disease and...
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Viveve hits the market Down Under
Viveve (NSDQ:VIVE) said today it it won regulatory clearance from Australia’s Therapeutic Goods Administration for its Viveve non-surgical treatment for post-partum laxity of the vaginal introitus. The...
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When an airport scanner sees a cyst as a security threat
(Reuters) – A traveler with a bulge in their body from a cyst or hernia might get flagged for an invasive airport security screening to look for explosives, a case report suggests. In many larger...
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FDA pushes back UDI deadline for convenience kit and repackaged device labelers
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have notified labelers of some Class II devices that their deadline for Unique Device Identification...
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Avedro taps Visiogen founder Zadno for CEO | Personnel Moves Sept. 9 2016
Avedro taps Visiogen founder Zadno for CEO Avedro said it named the founder, president of Abbott (NYSE:ABT) acquisition Visiogen, Reza Zadno, to be its new CEO. Zadno replaces CFO/COO Brian Roberts,...
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OEMs get in on $10m Series C for biosensor maker HMicro
HMicro said today that “dominant strategic OEM partners” joined a $10.2 million Series C round for the biosensor platform it’s developing for commercialization. Get the whole story on our sister site,...
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