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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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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Posted by
Matt Scheitlin on June 30, 2015
Medtech has always been known as an innovative industry. Most organizations are primarily focused on the next growth-driving product launch, whether it is an entirely new product category or a simple line extension. While this approach has been immensely successful in the past, many organizations are being forced to rethink their product strategy as the medtech environment changes.
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