ML10

Beautiful kids make great poster girls for campaigners trying to cut regulatory red tape and speed new technologies to market. But will the balance between too strict and too lax ever end up as “aaah, just right”?

When politicians get involved in issues some of us have spent decades involved with, the result is bound to have a few badly thought through components. In the case of the European MEPs they’ve done an acceptable job of identifying the medtech regulatory issues, tinged with a bit of populist reactionary stuff that would serve nobody.

FDA’s new report ostensibly focuses on patient safety… US patient safety that is. So it’s missionary work, but people of the rest of the world, who’s access to the newest medical technology is less restricted, might argue they’re fine as they are thanks.

68% of patients surveyed don’t think the medical devices industry is good at practising ethical marketing. Should we be surprised? Interesting survey from a global patient group audience.

Sounds like a simple idea cleverly executed, which makes University of Limerick researcher Dr Michael Walsh’s claims that this new balloon angioplasty device may advance the technique sound reasonable.

The conviction of an ex-Orthofix VP of Sales for violating US anti-kickback laws is a sick-making reminder that our industry is as vulnerable as any other to the lure of filthy lucre.

Two thought-provoking articles about what we can learn from innovations in the developing World.

Medical Device technology success stories happen every day and we take them for granted. This one’s pretty special though as London’s Great Ormond Street Children’s Hospital tells us about a 3 year old boy’s wait for a heart transplant.

Predictaresponse time. Heart Rhythm has refused to retract, which it was always likely to do. St. Jude might get the chance to respond in public as the journal offers to review its data.

It’s all getting a bit heated as Medtronic and St. Jude lock horns again, this time over the Hauser publication in Heart Rhythm journal.

According to St Jude, Dr Robert Hauser’s paper, accepted for publication in the Heart Rhythm Journal is biased and inaccurate, comparing apples with pears and peddling conclusions it’s own analysis cannot reproduce from the data set. Watch this space.

Promising signs for Abiomed as its percutaneously delivered high flow pump does the job for its first patient.

When it comes to Medical Device Regulation, a balanced assessment without fear nor favour is all we were looking for, so its refreshing to see someone else trying to counter the media frenzy.

Biomet has an exclusive, binding offer of $280M on the table for J&J’s DePuy Trauma division. The deal is thought to represent J&J’s concession, extracted from the leviathan by an EU commission, in order to ratify its $21Bn takeover of Synthes.

Human nature, behavioural economics, call it what you will, but the idea that the NHS can introduce telehealth at GP level with dictats and bungs doesn’t feel like winning management. Is this a good case for GP commissioning?

Thoughtful and insightful blog post from today on theheart.org