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Adding value to a study with safety monitoring oversight
Researchers agree that the highest standards in clinical research need to be preserved to maintain the public’s confidence in their work, competence, and ethics. With patient safety as a primary...
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What will make for tomorrow’s medical device winners – 3 key questions to ask
By Bill Booth, Director of Business Development There’s no argument that technology will continue to become a larger and larger part of our everyday lives. Just look at your personal electronics, car,...
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MassDevice.com +5 | The top 5 medtech stories for August 23, 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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Endologix touts 1st Ovation Alto stent graft implantations
Endologix (NSDQ:ELGX) last week announced that its Ovation Alto abdominal stent graft system has been used in its 1st 2 procedures to treat abdominal aortic anneurysms. The procedures were performed at...
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Admedus touts Phase II follow-on data for CardioCel
Admedus (ASX:AHZ) yesterday released results from the Phase II extension study of its CardioCel regenerative used to repair congenital heart defects in pediatric patients, touting no signs of...
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Gault must cough up Super Bowl ring in Heart Tronic case
Former NFL star and Heart Tronics executive Willie Gault is being ordered to turn over his Super Bowl ring by the U.S. District Court of the Central District of California, according to court documents...
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South African medical device regulatory system set for implementation
By Stewart Eisenhart, Emergo Group The South African government has set an August 2016 implementation date for registration of medical device manufacturers, importers and distributors first proposed in...
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UPDATE: Fitbit escapes Jawbone’s trade secret theft claims
Updated with comment from Jawbone. Fitbit (NYSE:FIT) yesterday beat rival Jawbone‘s accusations that it stole trade secrets for its wearable fitness tracking device when a judge for the U.S....
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Senators press Mylan on EpiPen price hike
By Sarah Faulkner UPDATED August 24, 2016, with comment from Hilary Clinton. Sens. Amy Klobuchar (D-Minn.) and Charles Grassley (R-Iowa) are pressing Mylan (NSDQ:MYL) for information on its 400% price...
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Sirtex Medical jumps on surging sales, profits for fiscal 2016
By Sarah Faulkner Shares in Sirtex Medical (ASX:SRX) closed up nearly 12% today after the Australian medical device company posted huge boosts to both the bottom and top lines. Sydney-based Sirtex...
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How medical device companies should think about patient engagement
Welcome to the Medsider interview series, a special new feature at MassDevice, which will appear regularly. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for...
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Researchers debut digestible battery
By Sarah Faulkner Researchers at Carnegie Mellon University unveiled an ingestible battery that could eventually power medical devices, including drug-delivery mechanisms. The inspiration came when...
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Fujifilm files last PMA module for Aspire Cristalle breast tomosynthesis...
Fujifilm Holdings (TSE:4901) said yesterday it filed its last Premarket Approval module to the FDA for its Aspire Cristalle breast tomosynthesis optional software upgrade for its Aspire Cristalle...
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Syneron Candela dumps Olympic swimmer Ryan Lochte
By Sarah Faulkner Syneron Candela (NSDQ:ELOS) this week severed its ties with Olympic swimmer Ryan Lochte, who was a spokesman for the aesthetic device company’s Gentle Hair Removal brand. “We hold our...
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SRS Medical launches Spanner prostate device study
SRS Medical Systems said today it enrolled the 1st patients in an FDA investigational device exemption study as it seeks to expand the indications for its Spanner temporary prostatic stent. The Spanner...
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FDA request delays timeline for Sanofi’s iGlarLixi drug-device combo for...
By Sarah Faulkner The FDA’s request for more data on the iGlarLixi drug-device combination for treating Type II diabetes pushed the timeline for a decision back 3 months, Sanofi (NYSE:SNY) and Zealand...
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Roche launches next-gen glucose monitor
Roche (PINK:RHHBY) said yesterday it launched its Accu-Check Guide next-generation blood glucose monitoring system, with an initial launch in Denmark, Switzerland and Australia. The new system features...
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MassDevice.com +5 | The top 5 medtech stories for August 24, 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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Covidien spinout Mallinckrodt to ditch nuclear imaging biz for $690m
Former Covidien spinout Mallinckrodt plc (NYSE: MNK) said today it is selling its nuclear imaging business to IBA molecular for $690 million. U.K.-based Mallinckrodt said it is hopeful that the deal...
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Ethicon, Touch Surgical debut surgeon training app
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon announced a strategic collaborative deal with healthcare tech platform developer Touch Surgery to develop a collaborative simulated surgical training...
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