This Week in Devices [12/7/2012]
FDA announces a partnership with the device industry to speed up device innovation. The IRS has released the final rules for the medical device tax. Certain plastics may be unsuitable for device implants. A brain pacemaker for Alzheimer's.
FDA Partnership to Speed Up Industry
With so much criticism thrown its way in regards to timeliness and efficiency, FDA can often seem like a whipping boy for the device industry. But, to the agency's credit, it is always working to resolve this. This week FDA announced that it will partner with the industry group, Medical Device Innovation Consortium, on a public-private partnership aimed at speeding up the development of new medical technology. [CBS News]
IRS Releases Final Rules for Medical Device Tax
With the medical device tax set to take effect in mere weeks the IRS has released its final rules for the new 2.3% tax. The tax is purported to raise $29 billion in revenue through 2022. However this does not mean companies have stopped lobbying against the tax for the burden it will lay on device makers. [Reuters
Plastics used in some medical devices, including those that keep the heart beating regularly, can break down in a previously unrecognized way.
Study Shows Some Plastics Are a Poor Choice for Devices
Silicon-urethane plastics are often used in medical devices including implantable devices like pacemakers. However a new study by the American Chemical Society has found that these materials can begin to break down in as little as 3-6 years when exposed to water. Previous studies have only looked at how these compounds break down with oxygen exposure, but these new findings could lead to new considerations and developments in device design. [ACS
A Brain Pacemaker for Alzheimer's Disease
The latest development in deep brain stimulation came as John Hopkins University researchers have announced that they have successfully surgically implanted a pacemaker-like device into the brain of a patient in the early stages of Alzheimer's disease. The device, which uses electrical stimulation within the brain, has been used to treat Parkinson's disease and has been suggested in the treatment of maajor depression and Tourette syndrome. Researchers are hoping it will provide a viable treatment for Alzheimer's patients. [Medical News Today