Top 10 device and diagnostic FDA approvals of 2012

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)


Suggested Articles

Fifteen of the 22 patients in a gene therapy trial no longer needed transfusions, while the remainder needed fewer transfusions.

Argos Therapeutics is ending its kidney cancer trial and mulling options, including a merger or sale, to stay alive.

CNS Pharma says berubicin is the first anthracycline drug to cross the blood-brain barrier and could transform treatment of the highly invasive brain tumor.