Medical Device Startups and the FDA

Does the FDA approval process impede innovation? Medical devices must be reviewed for safety and effectiveness by the Food and Drug Administration before being marketed in United States, which encompasses 43 percent of the global market for medical devices. Startups in the medical device industry are often dissatisfied with this approval process, favoring the FDA's European Union peer, CE Marking. Some founders even believe the time consuming and expensive FDA process "holds back the entire indu...
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Weekly Roundup on Entrepreneurship 3/31

Weekly Roundup is a McNair Center series compiling and summarizing the week’s most important Entrepreneurship and Innovation news. Here is what you need to know about entrepreneurship this week: Business Groups Hope Trump Can Change Health Law by Administrative Action Jeffrey Sparshott, Reporter, The Wall Street Journal Juanita Duggan, CEO of the National Federation of Independent Businesses, described the unraveling of the American Health Reform Act as “a dismal failure.” Despit...
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Weekly Roundup on Entrepreneurship 3/24/17

Weekly Roundup is a McNair Center series compiling and summarizing the week’s most important Entrepreneurship and Innovation news. Here is what you need to know about entrepreneurship this week: Congress Turns Its Attention to Entrepreneurship and Innovation — But Does It Take Effective Action? Anne Dayton, Research Manager, McNair Center The 115th Congress has passed 3 bills this legislative session relating to entrepreneurship and innovation. The tally seems abnormally high consideri...
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Entrepreneurship Weekly Roundup: 10/28/2016

 Weekly Roundup is a McNair Center series compiling and summarizing the week's most important Innovation and Entrepreneurship news. Here is what you need to know about entrepreneurship this week: Big Problems for Small Practices Catherine Kirby, Research Assistant, McNair Center for Entrepreneurship and Innovation Kirby examines the effects of the Affordable Care Act on entrepreneurship within health care. U.S. health care regulations currently hinder entrepreneurship among healthcare prof...
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