Every year, devicemakers secure patents, toil in labs, pile heaps of data and, finally, head to the FDA in search of a premarket approval that can make years of work worthwhile. A rejection can send stocks tumbling and investors reeling--just ask Navidea Biosciences ($NAVB) as it re-files for its diagnostic tool, Lymphoseek. And approval can mean an instant soar on the Street--or, in U-Systems' case, a prompt buyout from a multinational conglomerate.
Suffice it to say, the FDA is a kingmaker in the medical device and diagnostics industries. We've compiled the 10 biggest PMAs of 2012, looking at devices that promise to turn around ailing giants, technologies that have put startups on the map and diagnostics that hope to push personalized medicine closer to the norm.
To be clear, we're talking just PMAs, not 510(k) clearances. Countless important and market-changing products come through the 510(k) process--especially diagnostic tools and equipment--but those are all "substantially equivalent," and, for this list, we're more interested in innovative technologies that take the long way to the market. That said, take a look at 10 of the most important products to come out of the Center for Devices and Radiological Health unscathed last year. -- Damian Garde (Twitter | email)