The FDA is moving at two speeds in the medical device approval process. On the one hand, the agency is taking a critical look at the 510(k), expedited approval process, which has come under fire for being too lenient. The process will certainly see some change, given the pressure ensuing from high profile device failures [...]
With the FDA's approval of Medtronic's Melody Transcatheter Pulmonary Valve and Ensemble Delivery System (see link), another step has been made toward eliminating traditional surgery — at least that's the idea. The ability to implant a valve via a percutaneous procedure advances the art of less invasive intervention in ways akin to laparoscopic surgery, albeit at [...]
According to Dow Jones VentureSource data on second quarter 2009 venture capital investment, medical devices and biopharmaceuticals are driving a boost in VC investment to $5.27 billion. While this is still down from 2Q 2008 levels, it is a 32% increase over the first quarter of 2009. From the Dow Jones VentureSource press release: Health [...]
New FDA Commissioner Dr. Margaret Hamburg noted in a WSJ interview that she sees the FDA as a "public health agency" — not a radical notion for the entity charged with regulating food and drugs in the U.S. However, by putting this imprimatur on the agency she has made it clear, especially in light of [...]
Reading recent interpretations of “Value-Based Purchasing for Medical Devices“, it is not surprising to see, once again, the conclusion that medical technology is a significant source of rising healthcare costs. We all need to think outside envelope, though. Medical technology drives costs but also provides solutions we cannot resist. The tendency of healthcare cost analyses [...]
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