The U.S. Food and Drug Administration (FDA) wants manufacturers of medical products that the agency regulates to have more accurate labels regarding whether they contain natural rubber latex (NRL). In a draft recommendation, the agency is encouraging manufacturers of FDA-regulated medical products to stop having labels that say statements like “latex-free” or “does not contain [...]
FDA Seeks Comments on Limiting Weather’s Effects on Medical Device Industry
February 25, 2013 By Leave a Comment
The Midwest was hit last week with a blinding snow storm that put an inch of snow on the ground every hour in some places and walloped the area with 35 mph winds. Hurricane Sandy’s storm surge last October flooded New York’s streets and subways and devastated New Jersey communities. Events like these can interrupt [...]
Bionic Eye Helping People to See
February 7, 2013 By Leave a Comment
“We can rebuild him. We have the technology.” Those opening lines from the 1970s television show, “The Six Million Dollar Man,” just may be coming true in the 2010s. In the show, astronaut Steve Austin got a bionic eye after surviving a crash. Now people suffering from a rare genetic disease are the recipients of [...]
FDA Rules on Metal Hip Implants
January 24, 2013 By Leave a Comment
Manufacturers of metal-on-metal hip implants will need to prove that their medical devices are safe and effective before they could continue selling existing models or obtain approvals to sell new all-metal devices, according to a proposed rule from the U.S. Food and Drug Administration (FDA). The FDA’s action is intended to close a loophole in [...]
Medical Device Tax Could Suppress Innovation
January 22, 2013 By Leave a Comment
The new medical device tax will stifle technological innovation, say equipment lobbyists. The new health care law imposes a 2.3% tax on medical devices, requiring that manufacturers of the devices pay for the tax added to the sales price, reports Diagnostic Imaging. Some worry that the new cost will trickle down to providers and hinder [...]
Polymer Foam Reduces Internal Bleeding
January 17, 2013 By Leave a Comment
Medic! A shout often heard on the battlefield when soldiers are wounded. If the injury is internal and there is significant hemorrhaging in the abdominal area, the chances of survival past the first hour are slim. But thanks to a polymer foam developed by the Department of Defense’s Defense Advanced Research Projects Agency (DARPA) soldiers [...]
Polymer Scaffold Gets FDA OK
January 7, 2013 By 1 Comment
Health alert for athletes and weekend warriors! If you’ve ruptured a tendon or ligament or torn your rotator cuff, there’s a new procedure that can regenerate the tissue, rather than repair it or stitch it back together. Soft Tissue Regeneration (STR), a New Haven, Conn.-based company that makes early stage orthopedic devices, has received clearance [...]
Medical Device Excise Tax Set for Jan. 1, 2013
December 24, 2012 By Leave a Comment
A 2.3% excise tax will be imposed on the sales of medical devices, starting Jan. 1, 2013, because of the Health Care and Education Reconciliation Act of 2010. The tax is not helping the fiscal health of medical device manufacturers, which are facing large layoffs, the companies say. The Medical Device Excise Tax (MDET) applies [...]
FDA Wants Safer Use of Medical Devices at Home
December 20, 2012 By Leave a Comment
More people are using medical devices at home, and there are some safety risks involved in that trend, says the U.S. Food and Drug Administration (FDA). But resources are available to lessen those risks, the agency says. It used to be that patients needed medical devices just to stay alive. Now they help people be more [...]
Partnership Formed to Test Medical Devices
December 18, 2012 By Leave a Comment
The U.S. Food and Drug Administration (FDA) will help advance a public-private partnership that will work to give patients quicker access to medical devices. Many manufacturers have complained that the current approval process for allowing medical devices on the market is unnecessarily burdensome. But advances in regulatory schemes – the development of new tools and [...]
