Category Archives: FDA

Trust in government: 23 more reasons for suspicions

The number 23 is an interesting number. It’s a prime number, and is the number of pairs of chromosomes in human DNA, but it may also become a number FDA won’t soon forget. FDA recently issued a warning letter to…

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Med-tech community wary, but at the same time optimistic about the future of the sector

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…

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Should we be wary of surgical robots?

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….

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A refreshing take on the state of the med-tech industry

Here at Medical Device Daily we’ve become accustomed to the doom-and-gloom stories about our industry. The medical device tax provision in the Affordable Care Act and other emerging realities of healthcare reform along with worldwide economic sluggishness, regulatory and reimbursement challenges, consolidation…

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Speakers highlight strengths of med-tech industry

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…

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Meet the New CED

The Centers for Medicare & Medicaid Services has published a draft guidance for the new framework for coverage with evidence development, or CED, a very interesting framework indeed. Following is a list of some fascinating tidbits from the draft guidance….

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Chickens or lemmings? Washington and the FDA budget

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…

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FDA misconduct not deemed newsworthy

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…

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The future of device regulations: the EU model or the FDA approach?

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…

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Once again, the FDA budget dynamic

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…

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