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.
USA
1000 Knee Replacement Milestone For OMNI’s APEX Robotic Technology (“A.R.T.™”)
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.
US Device Tax: Looking For Beneficiaries Is Like Playing “Where’s Waldo?”
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.
FDA 510(k) Clearance for Maquet’s New Mega® Intra-Aortic Balloon Catheter Sizes
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’s Next Generation ICDs and CRT-Ds Gain FDA Clearance With Home Monitoring®
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 Clearance For First Below-The-Knee Embolic Capture Device
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.
Sanofi’s Blood Glucose Meter Now Available in U.S.
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.
US News Report On Euro-PMA
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 Clearance For Galt VTI™ Valved Tearaway Introducer
FDA has cleared Theragenics subsidiary Galt’s Valved Tearaway Introducer, opening the door for the company to gain access to a $14m market.
Is A Regulatory Goldilocks Zone Attainable?
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® Ventricular Assist System Gets FDA Panel’s Vote
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.
FDA Clears Abbott’s iFS Advanced Femtosecond Laser For Arcuate Incisions In Cataract Surgery
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.
U.S. Launch of Boston Scientific’s Z Flex-270™ Steerable Ablation Catheter Sheath
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.
For Cheap Medical Devices, Look To Developing World
Two thought-provoking articles about what we can learn from innovations in the developing World.
Telemedicine: The Future House Call?
Pardon our irreverence, but there’s a sitcom in here somewhere. The automated “housecall” is an obvious component in the provision of tomorrow’s healthcare, but the potential to get it wrong presents a minefield in which only certain patients with certain conditions will form the first wave.
First Patient Supported with Abiomed’s Impella cVAD™
Promising signs for Abiomed as its percutaneously delivered high flow pump does the job for its first patient.