Transcatheter Technology 2.0: How to Win in the New Marketplace

Posted by Sundeep Karnik on October 8, 2019

 

Transcatheter technologies transformed the treatment of coronary artery disease. From the first  percutaneous balloon angioplasty in 1977, to the first self-expanding stent in 1986 and first drug-eluting stent in 1999, to the biodegradable and bioresorbable stents we have today, many millions of patient lives have been saved and billions in economic value created.


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How the FDA's New 510(k) Guidelines Could Help or Hurt Medtech

Posted by Sundeep Karnik on January 14, 2019

Matt Singer co-wrote this blog post with Sundeep Karnik.

Recently, the FDA announced new steps to modernize its 510(k) regulatory clearance pathway. This is the first major overhaul of a process that has been in place since 1976. The FDA intends to implement three major changes:


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