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Ocular Therapeutix launches another pivotal for Dextenza eye drug-device combo
Ocular Therapeutix (NSDQ:OCUL) said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication....
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Mirowsky fights $6m legal tab in Medtronic spat
Mirowski Family Ventures, on the hook for a $6 million tab for Medtronic‘s (NYSE:MDT) legal costs, told a federal appeals court last week that a lower court misconstrued a 24-year-old deal with Eli...
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Report: Medicare proposal would broaden coverage for Boston Scientific’s...
The Centers for Medicare & Medicaid Services are reportedly considering broadening the coverage for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device, according to an unidentified...
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FDA plans Essure action for February
The FDA said today it will issue an evidence-based review of information on Bayer‘s (ETR:BAYN) controversial Essure permanent birth control for women in February next year. The agency said patient...
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BSN Medical picks up compression therapy maker Wright Therapy Products
BSN Medical said today that it expanded its footprint in the lymphedema treatment market with the acquisition of Wright Therapy Products for an undisclosed amount. Hamburg, Germany-based BSN has been...
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Cambridge Medical Robotics touts prototype, releases details on system
Cambridge Medical Robotics said today it completed construction and development of its 1st robotic surgical system prototype, and released details on the device it previously kept secret. The...
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Malaysian regulators issue updated conformity assessment guidance
By Stewart Eisenhart, Emergo Group The Malaysian Medical Device Authority (MDA) has published new guidance on its conformity assessment process in order to provide more information to authorized...
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Study: 3D MRI reveals early stroke risk in diabetics
A new study suggests that diabetes patients may be at a higher risk for stroke due to harboring advanced vascular disease, and that arterial imaging with 3D MRI could help determine stroke risk in...
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ThermoTek scores $7.6m win in battle with distributor
ThermoTek last week won a $7.6 million judgment plus interest from a distributor of its VascuTherm body heating and cooling system it accused of stealing trade secrets to develop its own competing...
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MassDevice.com +3 | The top 3 medtech stories for November 24, 2015
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: Medical device industry pumps $2.6B into Memphis economy
A study from the Greater Memphis Medical Device Council reports that the medical device industry has brought approximately 17,000 jobs and $2.6 billion. The study, which was funded by a grant from...
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UPDATE: Pfizer’s $160B Allergan buy sparks cry for tax-inversion crack down
Updated with extra politician comments and tax-inversion data. Pfizer (NYSE:PFE) said today it will buy Botox maker Allergan (NYSE: AGN) for approximately $160 billion and slash its tax bill in the...
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Theranos: A Cautionary Tale
By Michael Wienholt, RAC Recently, we’ve been receiving inquiries from some of our IVD clients about the latest developments with Theranos, Inc. They want to know if Theranos’ troubles indicate a...
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Dell gets into medical imaging, inks deal with Zebra
Dell (NSDQ:DELL) said today it jumped into the medical imaging market with its Dell medical Review 24 Monitor and signed a multi-year agreement with Zebra Medical Vision to distribute its Clinical...
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Dilon inks distro deal with GE Healthcare for breast imaging system
Dilon Diagnostics said it signed a deal with GE Healthcare (NYSE:GE) to distribute its GE Discovery NM750b molecular breast imaging system in select locations. The businesses said the agreement is an...
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FDA considers greater oversight of laboratory developed tests
By Stewart Eisenhart, Emergo Group US medical device and IVD regulators plan stronger oversight of laboratory developed tests (LDTs) as these products have become more widely used and riskier to...
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Xenios wins CE Mark for I-Cor cardiac assist device
Xenios said yesterday that it won CE Mark approval in the European Union for its I-Cor synchronized cardiac assist device, touting it as the world’s 1st “heartbeat-synchronized” cardiac assist for...
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Report: Ransomware on the horizon for medical devices
Life-saving medical devices could be held hostage by ‘ransomware’ as early as next year, according to a report from Forrester Research, Inc. Ransomware is effectively digital extortion – malicious...
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Fujifilm submits 2nd PMA module for tomosynthesis breast imager
Fujifilm Holdings (TSE:4901) said yesterday it filed a 2nd pre market approval module for a digital breast tomosynthesis upgrade for its Aspire Cristalle mammography system. The company expects to...
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Moximed wins CE Mark for Atlas ‘shock absorbing’ knee
Moximed said last week it won CE Mark approval in the European Union for its Atlas ‘shock absorber’ knee joint unloader for pre-arthroplasty patients. The Atlas system is an implantable joint unloader...
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