I’m very pleased and honored to be selected to serve on the Board of Advisors for Health in Place, an initiative to develop a new approach to considering innovations which impact health:

➪across the generations, recognizing the unique needs at various stages of life,

➪for each state of well-being, recognizing that they may be independent of age, and

➪regardless of location, recognizing that health is delivered and managed beyond the clinical setting, including —at and on the way to and from — home, school, work

Health in Place is an initiative of Disruptive Women in Healthcare with support from leading companies such as Philips and United Healthcare, and includes disruptive innovative technologies from Rock Health, a newly formed venture capital organization in Silicon Valley late in 2011. 

I’m here to look at the challenges that stand in the path of achieving the vision of HIP from a technology and regulatory perspective, and look forward to a busy 2012.   More on HIP as the year unfolds.

As I’ve previously reported in past blogs, the average review time for 510(k)s is about 140 days with about 2 review cycles.  This week, with the help of Anson, a small device manufacturer obtained FDA Clearance on a Traditional 510(k) …

The Institute of Medicien (IOM) press conference on their report Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years was held this morning. In the opening remarks it was noted that the conclusions presented within …

On July 19, 2011 FDA released its draft guidance for public comment on the use of mobile applications, or “apps” as they’re generally referred to (and which Apple is trying to trademark, but that’s a different matter). You can get …