It seems lately, the thing to do when one fails to achieve their desired result, is cry foul.  This can be true whether you’re an Olympic ice skater or a health policy leader.  This conclusion comes after reading the post from MassDevice interviewing Diana Zuckerman, about the recent FDA meeting reviewing the 510(k) process for clearing medical devices.  Diana Zuckerman is the president [...]

Much has changed in the FDA over the past year, and it appears more change is to come.  Issues surrounding device approvals under the 510(k) process were front-and-center in a public meeting this past Thursday. The meeting was titled by the FDA, “Strengthening the Center for Devices and Radiological Health’s 510(k) Review Process” and [...]

While the games are underway, bringing stories both great and tragic from the mountains of Vancouver, there is an unsung chronicle of the technology supporting these athletes in their quest for Olympic Gold. The Vancouver Olympic Committee estimates $5 million in medical equipment/supplies have been donated for the Games in 2010. In [...]

Before all this talk of “Snowmaggedon”, a beaming headline posted late last week stating that, “FDA Issues Guidance to Help Streamline Medical Device Clinical Trials”.  If you were hoping to learn how it works, you were in for a statistics lesson on Bayesian methods for designing studies and analyzing clinical data.  (Wait, don’t leave!)  Good [...]