dimecres, 23 de juliol del 2014

Occlutech claims another win over St. Jude Medical




Occlutech says a U.K. court invalidated a patent held by St. Jude Medical covering atrial septal occluder technology.








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Healthcare on the Potomac




Healthcare is on the move – in more ways than one. That's why executives from AirStrip launched Mobile Health Matters, a forum for ideas and opinions (some popular, some not-so-popular) on where the industry is headed and why. Mobility is changing the face of healthcare, touching everything from patient engagement to hospital quality metrics to care coordination. So we hope you'll join the conversation (and fire away – we can take it) and share your thoughts on healthcare's mobile transformation.





Healthcare on the Potomac

by Mike Mitsock




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DARPA taps NeuroPace for memory loss trial




NeuroPace teams up with the Defense Advanced Research Projects Agency to examine use of implanted neurostimulators to help restore memory.





DARPA taps NeuroPace for memory loss trial

Epilepsy treatment devices maker NeuroPace hopes to expand its clinical applications by supporting a research initiative to evaluate neurostimulation implants in treatment of memory deficits.




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Ulthera pulls $86M IPO in favor of $600M merger




Aesthetics devices maker Ulthera withdraws its $86 million initial public offering after agreeing to an acquisition by Merz that's valued at up to $600 million.





Ulthera pulls IPO in favor of merger

Arizona device maker Ulthera is ditching its planned initial public offering in favor of a $600 million merger with larger aesthetics company Merz Inc., according to an SEC filing.




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Judge nixes alleged settlement in Stryker, Biomet poaching spat




A Michigan federal judge denies a settlement in the poaching spat between Biomet and Stryker and a pair of ex-Stryker sales reps.








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Russian regulators preparing new medical device classification system?




The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.





Malaysian medical device regulators change requirements for docs, AI requests

By Stewart Eisenhart, Emergo Group




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dimarts, 22 de juliol del 2014

Medicare's Sunshine Act changes could hit device makers in the pocketbook




The Centers for Medicare & Medicaid Services proposes 4 changes to physician payment transparency rules that could mean major new costs for medical device makers.





Sunshine: CMS outlines 4 changes to physician payment transparency rules

Medicare regulators are looking for feedback on proposed changes to the laws governing transparency in financial relationships between doctors and healthcare companies, warning that the changes may represent a hefty new cost for medical device makers in particular.




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