Regulatory

We can’t even harmonise the spelling of the word harmonize, so what chance of bringing our regulatory processes closer together?

Another approach to reducing calorific intake is demonstrated with the newly CE marked Satisphere device, an endoscopically inserted series of balloons on a wire, which retain gut contents in the duodenum for longer, creating the feeling of satiation and therefore reducing appetite.

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

Whether you’re Synthes, J&J, Boston Scientific or especially Cameron Health, it’s been a pretty good week. Now all we need to do is see a resolution to the endless regulatory debates both sides of the pond and we’ll be happy. Won’t we? Did somebody say 2.3% device tax?

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”?

Champagne corks will be popping at Cameron Health as FDA’s expert panel review results in a vote in favour of its subcutaneously implanted S-ICD® device. FDA approval is expected to follow within 12 months.

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.

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.

April 26th is FDA Circulatory Panel decision day for Cameron Health’s S-ICD device. Not much resting on it… only $150m.

The FDA has chosen attack as its best form of defence this week as it adopts a very aggressively critical stance over EU regulatory failings. It’s a bit rich though isn’t it when data suggesting EU regs are harming patients seems to be thin on the ground.

Single study shows novel hydrogel scaffold results in better wounds. Product gets CE mark. Should it really be that simple?

Boston Scientific is having a good week, not least with the news that its super fine Emerge PTCA balloon catheter has gained its CE Mark.

More pacing leads from St.Jude are now at risk of externalisation according to a new MHRA medical device alert.

Not that breast implants set off any alarm bells or anything: Breast augmentation filler Macrolane may obfuscate the results of mammograms to the extent that its manufacturer has removed the indication and issued directions on how to treat patients with the filler in place. UK competent authority the MHRA has seen fit to issue an alert along the same lines to draw attention to it.

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.

Sotera Wireless Inc is on a mission to improve vital signs monitoring in ambulatory patients. FDA clearance of the company’s ViSi Mobile™ System has just been announced.