It’s quarterly financials time… pretty tedious fare, but we have a go at spicing it all up a little. Well someone has to because there’s not much room for humour in it all.
Taken at face value some new data and reporting suggests that a U.S. style PMA might deliver little benefit in terms of patient safety, yet delay innovations from reaching the market by 43 months. We argue it’s more subtle than that.
If you’re a medtech company with a new product or just a need for a higher profile, give it ten minutes and you’ll come up with stories that can become online assets. So why are we all so coy?
Consumers Union is a powerful patient rights advocacy group in USA, and as such it’s perhaps not surprising to see it welcoming the Unique Device Identifier proposals from FDA… and asking why it’s taken so long.
Richard Smith says it’s time to open up the finances of medical journals so we can see whether lucrative reprint business is risking clouding judgement. A bit more transparency about publications’ sources of income would perhaps provide comfort.
Back in February US congressional watchdog, the Government Accountability Office asked FDA to implement more stringent testing of medical devices before market release. Four months on a law firm sees fit to make a meal of it.
It’s industry body Eucomed’s job to be the cheerleader for Europe’s medical device industry members. And when Eucomed speaks, we listen. However, in what we’re hoping is a healthy contribution to the debate, we’re taking issue with some aspects of regulatory director John Brennan’s latest blog in which he is arch defender of the status quo.
BAAPS has issued a statement broadly supporting the conclusions of the Chief Medical Officer’s report into the PIP breast implant situation. The association is urging women to take up the offer of consultation and potential explantation, and urging the private sector providers to do exercise their own duty of care.
We seem to be writing about Renal Denervation every few weeks as the players unveil their latest approval of latest study result. So we thought it worth stepping back and considering the state of play for a moment.
It puts events in perspective when a natural disaster the size of that which has hit Italy in recent weeks is translated into what it really means for local people and businesses. Eucomed’s feature says it all and is an appeal for help.
The harbingers of doom would have it that the medtech sales tax bit of Obamacare would reduce investment in innovation and in so doing kill people by not offering them lifesaving technologies that haven’t yet been invented. Mad argument maybe, but the real point is how well medtech industry has campaigned against the tax.
Medlatest is pausing for breath over the early part of next week as we honour the Queen’s 60th year on the throne. Forecast; Rain.
While we’d all have preferred not to have seen the recent PIP/Hip problems, there’s no doubt in our mind that the hubbub presents a unique opportunity to adopt measures that could show the world how to do this stuff.
Medical Device news roundup for week ending May 25th.
Covidien’s quietly recalling its Roticulators for packaging concerns, but seems to be doing so by stealth rather than adopting the slightly more communicative route one might expect to see.
It’s been a fascinatingly diverse week with a steady flow of medical device news. It’s notably been a week containing a cardiovascular congress in Paris (EuroPCR) and an arthroscopy congress in Orlando (AANA). Anyway, it’s online right now.