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FDA clears ScandiDos radiation dose monitor
Swedish dosimetry company ScandiDos said yesterday it won FDA 510(k) clearance for its Delta4 Discover device designed to verify radiation doses delivered to patients during radiation treatments. The...
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BU researchers examine how spinal structure affects fracture rate
A Boston University mechanical engineering professor is attempting to improve spinal fractures predictions using an unusual set of tools – the same used for analyzing stress and strain on bridges and...
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Calmare wins $15m DoD contract
Pain mitigation company Calmare Therapeutics said yesterday it won a general supply order contract from the U.S. Department of Defense for an estimated $15 million over the next 60 months. The...
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Setting non-sales targets in medical device distribution agreements
By Edgar Kasteel, Emergo Group So you found a great distributor—now what? Medical device manufacturers often underestimate the time and money needed to establish and nurture distributor relationships....
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FDA panel votes against Medtronic’s DIAM spine stabilization system
An FDA advisory panel last week reportedly recommended against approval for the DIAM spinal stabilization system made by Medtronic (NYSE:MDT) The federal safety watchdog’s Orthopaedic &...
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Medicare contractor won’t cover St. Jude Medical’s CardioMEMS heart monitor
A Medicare contractor last week said it would not cover the CardioMEMS implantable heart monitor made by St. Jude Medical (NYSE:STJ), citing the need for more clinical data on the device. Novitas, a...
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FDA approves trial for low-risk patients with MDT’s CoreValve Evolut R
Medtronic (NYSE:MDT) said today that the FDA granted an investigational device exemption for a clinical trial of its CoreValve Evolut R implantable heart valve in patients at low risk for adverse...
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Boston Scientific wins CE Mark for Eluvia peripheral stent
Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for its Eluvia peripheral vessel stent for above-the-knee procedures. Marlborough, Mass.-based Boston...
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ReCor Medical to launch U.S. trial for Paradise renal denervation device
ReCor Medical said today that it won an investigation device exemption from the FDA for a clinical trial of its Paradise renal denervation device for treating high blood pressure. Palo Alto, Calif.,...
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Mitralign wins CE Mark for namesake heart repair device
Mitralign said today that it won CE Mark approval in the European Union for its namesake device for treating functional mitral regurgitation. Tewksbury, Mass.-based Mitralign said the approval covers...
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Medtronic wins CE Mark for line of MR-safe CRT-Ds
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its full line of magnetic resonance imaging safe cardiac resynchronization therapy defibrillators, now approved for...
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Scientists expose superbug defenses
(Reuters) — Scientists in Britain have found how drug-resistant “superbug” bacteria build and maintain a defensive wall – paving the way for the development of new drugs to break through the barrier...
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Artificial lung developer ALung raises $12m
Artificial lung-like device developer ALung Technologies said today it closed a $12 million round of financing to support the continued commercialization of its minimally invasive Hemolung Respiratory...
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Last day to renew FDA medical device registrations for FY 2016
By David Lennarz, Vice President and Co-Founder of Registrar Corp In early February, the U.S. Food and Drug Administration (FDA) sent e-mails to medical device establishments that had not yet renewed...
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Precision Ocular raises $19m, inks deal with Consort Medical for drug-device...
Consort Medical said today it inked a development and manufacturing deal with Precision Ocular, and joined in a round of financing to support Precision Ocular, who raised $19 million (UK £13.5 million)...
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Unilife & Amgen finalize $75m co-development deal
Unilife (NSDQ:UNIS) said today it finalized a $75 million collaborative deal with Amgen (NSDQ:AMGN) for injectable drug delivery systems, a deal the companies have been working out for the past month....
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MassDevice.com +3 | The top 3 medtech stories for February 22, 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 to debut wearable hospital monitors, inks deals with 4 healthcare...
Royal Philips (NYSE:PHG) today revealed plans to launch a series of wearable monitoring solutions for at risk patients in a hospital setting alongside announcing multi-year telehealth deals with 4 U.S....
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Ex-accountant sues Hologic over termination
An ex-Hologic (NSDQ:HOLX) accountant is suing the company after allegedly being terminated for reporting on possible illegal accounting practice that included reclassifying accounting numbers to show...
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ResMed to pay $800m for cloud-based software firm Brightree
ResMed (NYSE:RMD) said today it will pay $800 million to acquire cloud-based healthcare software company Brightree. Atlanta, Ga.-based Brightree develops cloud-based software for home or durable...
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