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More From EuroPCR As Edwards Announces Sapien XT 30 Day Results

Edwards Lifesciences’ Sapien XT may not be FDA cleared, but in Europe at least the company is generating a nice body of data suggesting that at least in the short term the valve performs well in high risk patients. These data have been presented at EuroPCR 2012 in Paris this week.

18 May 2012

Medical Device News and Views Delivered Every Day

EU Falls Into Regulatory Knee-Jerk Trap In Response To PIP Scandal

When politicians get involved in issues some of us have spent decades involved with, the result is bound to have a few badly thought through components. In the case of the European MEPs they’ve done an acceptable job of identifying the medtech regulatory issues, tinged with a bit of populist reactionary stuff that would serve nobody.

26 April 2012

CE Mark For Ekso Bionics “Exoskeleton” Enables Wheelchair Users To Stand And Walk

State of the art materials lie at the heart of this incredibly liberating exoskeleton for people with spinal cord injuries. The definition of a medical device, for CE mark purposes stretches from cranberry pills to exoskeletons it seems as Ekso Bionics announces gaining of clearance to market in Europe.

18 May 2012

It’s AANA Time. If You Can Name A Joint They’re Discussing Putting A Scope In It

AANA is probably the world’s best known annual forum for all things arthroscopy. It’s being held right now in Orlando and the program looks like the usual excellent selection of guest speakers and papers.

17 May 2012

US Purchasers Urge Taxman To Prevent Medtech Industry Windfall

Hospitals and purchasers have woken up to the threat that medical device companies will find ways to dump the burden of the 2.3% tax levy on them. So they’re lobbying the taxman to make sure there are no loopholes through which companies can jump to deduct the tax from income while also passing on the costs to the customer.

17 May 2012

Covidien Completes Acquisition of superDimension, Ltd.

Covidien told us in March it was to acquire Israeli company superDimension. The deal is now done in a transaction worth $300M plus earnouts.

16 May 2012

Merit Medical’s 200 Irish Jobs Boost

Merit Medical Systems will be recruiting up to 200 staff over the next five years at its newly opened €20M Galway facility, already an employer of 379. The aim is to make the facility the company’s centre of excellence for new product and technology development.

18 May 2012

It’s been a fascinatingly diverse week with a steady flow of medical device news. It’s notably been a week containing a cardiovascular congress in Paris (EuroPCR) and an arthroscopy congress in Orlando (AANA). Anyway, it’s online right now.

State of the art materials lie at the heart of this incredibly liberating exoskeleton for people with spinal cord injuries. The definition of a medical device, for CE mark purposes stretches from cranberry pills to exoskeletons it seems as Ekso Bionics announces gaining of clearance to market in Europe.

Not satisfied with just drug elution as a means of reducing neointimal hyperplasia, OrbusNeich has built in an Endothelial Progenitor Cell capture coating which appears in this blinded study to improve neointimal appearance at 9 months.

Merit Medical Systems will be recruiting up to 200 staff over the next five years at its newly opened €20M Galway facility, already an employer of 379. The aim is to make the facility the company’s centre of excellence for new product and technology development.

Edwards Lifesciences’ Sapien XT may not be FDA cleared, but in Europe at least the company is generating a nice body of data suggesting that at least in the short term the valve performs well in high risk patients. These data have been presented at EuroPCR 2012 in Paris this week.

AANA is probably the world’s best known annual forum for all things arthroscopy. It’s being held right now in Orlando and the program looks like the usual excellent selection of guest speakers and papers.

One benefit of being a commentator on the medtech industry is that we get faced with masses of information to distil into something meaningful. Just occasionally it’s nice to have a time-out and ruminate on what we’re seeing happening and how that might pan out.

Covalon’s IV Clear™ Silicone dressing is comfortable to wear and remove and contains two antimicrobial components within its adhesive layer, making it a compelling proposition in the market for securement of such as IV access devices. Now the product has FDA clearance to add to its Health Canada approval.

Views from the Med

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View From the Med

take a View from the med iconwith so much going on in the world of medical technology, medlatest likes to reflect each week on the big news items of the past seven days.