USA

FDA’s circulatory devices panel review meeting last week, a routine scheduled event, has been widely reported as ordering some sort of panic stricken review of St.Jude’s Amplatzer® device. The reality was altogether less of a headline grabber.

Consumers union is bent on regulatory tightening and even resorting to print ads in its quest to convince Joe Public that the evil medical device manufacturers are trying to harm him. One wonders whether they have the right objective in mind though because the regulatory regime they might end up with could actually stifle innovation and be more harm to Joe Public than the present set-up.

Hospitals and purchasers have woken up to the threat that medical device companies will find ways to dump the burden of the 2.3% tax levy on them. So they’re lobbying the taxman to make sure there are no loopholes through which companies can jump to deduct the tax from income while also passing on the costs to the customer.

We’d not heard of them, but it appears that Orthopedic Synergies Inc’s burgeoning portfolio of companies including OMNILife sciences Inc, have been quietly getting on with developing and implanting their computer assisted Apex knee replacement to the tune of 1000 patients.

Following last week’s coverage of Joe Hage’s no2point3 campaign, John Eckberg, Cook Medical’s Director of Media Relations has provided us with his own (and presumably Cook’s) view of the matter. It’s no surprise, given Cook’s previous well-expressed vehement antipathy towards the bill, to find the company broadly supportive of the campaign to repeal the act, specifically the medical device company tax levy.

MAQUET Cardiovascular LLC has announced that it has received FDA 510(k) clearance for its new MEGA 7.5Fr. 30cc and 40cc intra-aortic balloon (IAB) catheters. These new, larger volume catheters will allow clinicians to provide patients with greater haemodynamic support, regardless of their height.

Biotronik ticks another big box with the FDA clearance of its Lumax 740 ICDs and CRT-Ds equipped with home monitoring, supporting the company’s claim to have the only CE and FDA approved remote cardiac patient management system for early detection of clinically relevant events.

FDA has cleared Angiodslide’s tiny Proteus™ device for balloon angioplasty and embolic capture in peripheral vessels. It works by folding in on itself on deflation, in so doing drawing the embolic fragments into a sort of inverted balloon-bag. Clever.

A little over four months after gaining FDA clearance Sanofi’s Glucose meter, which interfaces with an iPhone, is now commercially available through selected stores in the US. It’s been available for a while in most of Europe.

More coverage of the barmy Eurocrats’ recommendations for new EU medical device legislation. There’s nothing like a good scandal to get politicians chasing votes, and imposing draconian new rules might create more problems than the one they’re designed to address.

FDA has cleared Theragenics subsidiary Galt’s Valved Tearaway Introducer, opening the door for the company to gain access to a $14m market.

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”?

Heartware’s Ventricular Assist Device was expected to get the FDA Circulatory Systems Advisory Panel support, so it’s no surprise that it’s happened. FDA approval is expected to follow.

Femtosecond laser technology is fairly new to the ophthalmic surgical profession, especially in the US. Now FDA has cleared Abbott’s device for the creation of curved incisions in corneal surgery including cataract access.

Boston Scientific has announced the immediate launch of its new Z Flex-270 steerable sheath to enable Cardiologists to precisely steer ablation catheters of up to 12F to target tissue.

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