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FDA: Recall of Arkray Spotchem II test strips is Class I
Arkray is recalling its Spotchem II test strips over inaccurate blood sugar readings in what the FDA has labeled a Class I recall. The FDA labels recalls as Class I when there is a reasonable...
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MassDevice.com +3 | The top 3 medtech stories for January 29, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the...
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Study: No benefit for biological mesh in hernia repair
Using biologic mesh for abdominal wall hernia repair provides no benefit over using cheaper synthetic mesh, according to a new study from the UT Southwestern Medical Center that compared the 2...
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Medtronic to present Micra data at FDA leadless pacer committee meeting
Medtronic (NYSE:MDT) said today it will present data on its Micra transcatheter pacing system at an FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee. The Micra...
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Innfocus touts 3-year MicroShunt data
InnFocus said Wednesday that results from a 3-year trial of its MicroShunt drainage system designed to treat glaucoma patients reported a significant reduction in intraocular pressure and the use of...
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Smith & Nephew CEO to stay on during cancer treatment
Smith & Nephew (NYSE:SNN) said today that CEO Olivier Bohuon plans to remain “actively involved” in running the British healthcare giant during his treatment for a “highly treatable” type of...
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US FDA issues design, submission recommendations for interoperable devices
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have published new guidance targeting how manufacturers of electronic interoperable devices design...
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Report: IPO market continued to slump in January
The market for initial public offerings continued its slump in January, confirming forecasts for a 6-year low, according to Renaissance Capital. No IPOs priced last month, making it the slowest January...
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Becton Dickinson dodges hospital’s anti-trust suit
Becton Dickinson & Co. (NYSE:BDX) dodged an anti-trust lawsuit brought by a Georgia hospital system after a federal judge ruled last week that the plaintiff lacked standing in the putative class...
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Stryker to pay $2.8B for Sage Products ‘never event’ devices
Stryker (NYSE:SYK) said today that it inked a deal to pay nearly $2.78 billion for Sage Products and its line of disposable devices designed to reduce so-called “never events” in intensive care and...
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Medtronic gets into renal care with Bellco acquisition
Medtronic (NYSE:MDT) said today that it acquired renal care products make Bellco for an undisclosed amount and plans to fold it into a newly created renal care solutions division. Fridley, Minn.-based...
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Medtech M&A madness: Abbott to pay nearly $6B for Alere
Abbott (NYSE:ABT) said today that it agreed to put nearly $6 billion on the table for diagnostics giant Alere (NYSE:ALR), saying it aims to become the leading point-of-care testing provider with annual...
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Amgen, Unilife extend talks on exclusivity deal
Unilife (NSDQ:UNIS) and Amgen (NSDQ:AMGN) are giving themselves to the end of the week to come to an agreement on whether their deal for Unilife’s wearable injector technology will be exclusive to...
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Medtronic wins expanded CE Mark for larger Resolute Onyx stent
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for a expanded indications and sizes for its Resolute Onyx drug-eluting stent. The Resolute Onyx device is based on...
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J&J’s Ethicon recalls Gynecare Thermachoice III cath on shelf life issues
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said it is recalling its Gynecare Thermachoice III thermal balloon ablation silicone catheters over issues with the labeled 2-year shelf life. The...
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LivaNova wins FDA nod for Crown PRT stented heart valve
LivaNova (NSDQ:LIVN) said today it won FDA premarket approval for its Crown PRT stented aortic heart bioprosthesis for treating aortic valve disorder. The Crown PRT is designed for aortic valve...
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MassDevice.com +3 | The top 3 medtech stories for February 1, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the...
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Philips issues urgent safety notice for Allura systems
Royal Philips (NYSE:PHG) issued a set of field safety notices for its Allura Xper system, icnluding the FD, Centron, Clarity and CV20 models over issues with failing alarms and unexpected system...
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Glaukos taps direct sales force for Canadian iStent launch
Glaukos (NYSE:GKOS) said today it created a direct sales organization to commercially launch its iStent inject trabecular micro-bypass stent for alleviating intra-ocular pressure. The iStent Inject is...
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Hansen Medical touts robotic-nav afib ablation study data
Hansen Medical (NSDQ:HNSN) today released data from a study involving the use of its Sensei X robotic navigation system during pulmonary vein isolation procedures, touting a 100% procedure success...
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