The FDA's premarket approval process for first-time products worked at a sluggish pace through much of 2013. But some noteworthy med tech devices and tests still made it through the regulatory bureaucracy.
That's the basis of this FierceMedicalDevices special report, with a focus on top premarket approvals that came through last year. The list is by no means all-encompassing. Rather, it simply focuses on products that we view as standouts in a larger list of impressive technology. These premarket approvals have the potential to truly improve the standard of care in a way that could actually measure up to the hyperbole that companies typically espouse in these situations.
New products that made it through the premarket approval process in 2013 include a retinal prosthesis system designed to treat an inherited condition that can cause blindness, a computer-assisted sedation system and a cervical disc replacement that can help patients avoid spinal fusion--a more drastic surgical option. There's also an anti-epilepsy neurostimulation implant, and the first major advance in breast implants approved in quite some time.
Beyond the achievement of winning FDA approval, these companies can celebrate having successfully navigated a difficult regulatory labyrinth made worse in 2013 because of bitter congressional budget battles over mandatory budget cuts known as the sequester. This process kept vital funding from the FDA, including money generated by user fees paid by the industry, ironically intended to help make the approval process more transparent and efficient.
Keep in mind, there were other premarket approvals in 2013. Again, we chose to focus on standout, first-time approvals. One approval on our list also came through by way of a de novo premarket approval, a related, regulatory substatus that's one of many options companies pursue in the hopes of reaching the market.
Below, please follow the links to the 2013's top FDA approvals. Let us know your thoughts, and thanks for your interest. -- Mark Hollmer (email | Twitter)