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Medical Device Numbers 101
GeneralReaders often contact us asking about the overall size of the medical device market and similar general statistics. Here’s what we found.
November 29, 2010
1 Min Read
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$94.9 billion: Estimated value of U.S. medical device market in 20101
17.7%: Healthcare's percentage of GDP2
The United States’ health expenditure is projected to reach $2.6 trillion for 2010, which is about 17.7% of the GDP.2
1. Espicom Business Intelligence; 2. CMS Office of the Actuary
Regulatory
It’s been a tough year (or two) for FDA, especially where the 510(k) process is concerned. And industry didn’t make it easier, submitting more 510(k)s than it has in at least five years.
1300: Approximate number of current part- and full-time CDRH employees
100: Approximate number of times FDA has ever rescinded a 510(k) clearance
1: Approximate number of 510(k) rescissions in which FDA admitted making an error
FY 2009 Submissions to FDA3
510(k)s: 4153
PMAs*: 512
** includes original PMAs, panel-track PMA supplements, premarket reports, expedited original PMAs and panel-track PMA supplements, 180-day PMA supplements, and real-time PMA supplements
3. FY 2009 Performance Report to Congress
Imaging
Imaging was one of the dominant medtech headlines for 2010, whether for controversial mammography guidelines (click here for a bonus section on mammographies) or excess radiation doses. Here are some of the numbers behind the fuss.
Annual Spending on CT Imaging4
2000: $975 million
2007: $2.17 billion
Roughly 80% of the ionizing radiation most people get in their lives comes from radon gas, cosmic rays, and other natural sources—even bananas.5
4. Government Accountability Office; 5. Los Angeles Times
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