massdevice
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Hospitals
Medtech insiders respond to FDA’s 510(k) split-predicate ban
August 6, 2014 by Arezu Sarvestani The FDA’s new guidance against split predicates in medtech 510(k) applications gets a largely warm welcome…
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Financial
Medtronic, Covidien merger: Ishrak and Almeida go on tour
August 5, 2014 by Arezu Sarvestani The chiefs of Medtronic and Covidien hit the road to visit a slew of company sites…
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Financial
Report: Medtech M&A exits don’t hinge on FDA approval
July 31, 2014 by Arezu Sarvestani Medical device startups face significant headwinds in finding funding and getting to an exit,…
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Hospitals
Medical device makers face new obstacles to European approval
July 30, 2014 by Arezu Sarvestani New materials regulations in the European Union mean medical devices have one more layer of red…
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Hospitals
Final rule prohibits “split predicates” under 510(k) process
July 29, 2014 by Arezu Sarvestani Medical device regulators clamp down on the 510(k) review pathway, prohibited manufacturers from splitting their primary…
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Smith and Nephew, other medtech giants weigh in on mega-mergers
July 29, 2014 by Arezu Sarvestani A recent spate of mega-mergers hasn’t inspired medtech peers to follow suit just yet, according to…
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Uncategorized
Exclusive: IRS collected $1.4B in medtech excise tax payments in 2013
July 28, 2014 by Brian Johnson The IRS calculates that medtech companies paid the federal government $1.4 billion in medical device excise…
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Recon
Smith & Nephew CEO reveals new ‘no frills’ strategy
July 28, 2014 by Brad Perriello Smith & Nephew CEO Olivier Bohuon reveals a new, ‘no frills’ strategy for developed markets that…
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US FDA publishes insight into 510(k) Substantial Equivalence determination process
July 21, 2014 by MassDevice The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest…
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Uncategorized
Could Medtronic-Covidien deal get caught in anti-inversion legislation?
July 16, 2014 by Arezu Sarvestani Lawmakers aim to prohibit companies from shifting their headquarters overseas in order to evade U.S. taxes,…
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Biologics
Getting the most of mesenchymal stem cell transplants
Vector is Children’s Hospital Boston’s blog about research and innovation in pediatric and adult medicine. We report and comment on…
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Robotics
Bionics maker BIOM taps Charles Carignan for CEO role
July 7, 2014 by Brian Johnson Dr. Charles Carignan, the former CEO of Ninepoint Medical, joins BIOM as its next CEO. BiOM…
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Uncategorized
Convictions stand for ex-ArthroCare execs in $400M fraud scheme
July 3, 2014 by Brad Perriello The a federal judge declines to overturn the convictions of former ArthroCare CEO Michael Baker and…
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FDA proposes enforcement discretion for medical device data systems
June 30, 2014 by MassDevice By Yarmela Pavlovic and Jennifer Henderson In a 20 June 2014 draft guidance, the Food and Drug Administration…
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Uncategorized
Healthcare’s ‘sloppy’ with security, hacker says
June 30, 2014 by Arezu Sarvestani Too many hospitals have unsecured computer terminals that expose sensitive networks and leave every single internet…
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