The MedTech Investing Conference held each May in Minneapolis is one of the more interesting investor-focused gatherings on the calendar. It always earns accolades from attendees as representing one of the best opportunities to bring together venture capitalists, entrepreneur/innovators and…
In a recent issue of Medical Device Daily, Integrity Life Sciences (ILS; Tampa) reported that FDA will investigate the use of robotic surgery, a move said to be sparked by a tripling of adverse events reports between 2008 and 2012.
ATLANTA – With a substantially strong turnout the Southeastern Medical Device Association (SEMDA) kicked off its 2013 conference earlier today. Hosted at the Georgia Institute of Technology Global Learning Center, the organization’s annual conference featured speakers ranging from Medical Device…
The Centers for Medicare & Medicaid Services has published a draft guidance for the new framework for coverage with evidence development, or CED, a very interesting framework indeed. Following is a list of some fascinating tidbits from the draft guidance.
There’s a lot of consternation and maybe even a little constipation of late about the U.S. federal budget, and rightly so. If the White House and Congress can’t come to some resolution about budget sequestration, the FDA budget could tighten…
By Kelly Roman, Vice President of Fisher Wallace Labs On February 10, 2012, the FDA convened an advisory panel hearing on whether to reclassify cranial electrotherapy stimulation (CES) devices. Despite being a low-risk device, CES has lingered in Class 3…
The demise of the Global Harmonization Task Force as a regulator-plus-industry forum for harmonization – or “convergence,” as the cautiously optimistic like to say – was met with little more than silence from the trade associations, but one can be…
No doubt some are tired of hearing me go on about the FDA budget, but industry thinks the agency is under-funded, too. Most who are part of this discussion believe FDA would be more functional with appropriate appropriations, but they…
In the March 15 issue of Medical Device Daily, there were two stories that discussed the medical technology industry in the U.S., and neither of them cast a particularly flattering light on the current state of affairs. In fact, it…
