R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.


Regulatory Intel - Jan. 21, 2013

Wrap-up of a few notable news stories from last week:

New Year, New Resolutions

Happy New Year - I hope that all of our blog readers had a wonderful holiday and brought in 2013 with warm and welcoming arms!

More changes heading our way?

After a recent statement by the EU health commissioner, it appears that FDASIA's influence may have gone abroad. As the medical device industry gears up and is adapting to the changes that FDASIA brings, it may also have to prepare itself for even more changes heading our way.

Mobile Medical Applications: Innovation vs. Regulation

Mobile apps are absolutely exploding on the marketplace. It seems like so many business entrepreneurs are focusing on creating new apps that fit various needs such as games, music, organizational purposes and the list goes on. I recently read an article that discussed creating a Mobile Health office within the FDA. Specifically focusing on health alone, there are thousands of mobile apps that focus on counting calories, recording miles walked, and monitoring blood sugar levels.

Nano-what? Nanotechnology.

Over the past 50 years, the advancement of technology has been beyond incredible. Although, we are not zipping around in flying cars, fearing the dreaded encounter with a hoverboard gang, or living amongst cyborgs, we are witnessing things never before thought possible. Such innovations include robotic performed surgeries, implantable drug-eluting stents (DES), and the ability to “print” skin grafts.

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