The Medical Device Business Journal — Medical Device News & Articles | MassDevice
A study funded by the National Institutes of Health found that lubrication in metal-on-metal hip implants has more in common with the lubrication in a combustion engine than a natural joint.
The study, conducted by U.S. and German researchers, found that a lubrication layer that forms in metal-on-metal hip replacement devices is actually graphite carbon, not proteins as researchers previously suspected.
Welcome to MassDevice’s annual audit of the ups, downs and in-betweens of the year that was. For the medical device industry, 2011 was more or less defined by a nagging sense of uncertainty that hung over the world’s med-tech companies like a grey cloud above a summer picnic.
But what did we learn from all the conjecture? In truth, not much. The year ends much as it began, full of questions with no cut and dry answers as we turn the calendar over into the new year.
Welcome to MassDevice’s annual audit of the ups, downs and in-betweens of the year that was. For the medical device industry, 2011 was more or less defined by a nagging sense of uncertainty that hung over the world’s med-tech companies like a grey cloud above a summer picnic.
But what did we learn from all the conjecture? In truth, not much. The year ends much as it began, full of questions with no cut and dry answers as we turn the calenFdar over into the new year.
MASSDEVICE ON CALL —The Medical Device Patient Safety Act, introduced this week in the Senate, calls for increased safety measures for device approval from the FDA.
The bill, introduced by Sens. Chuck Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.), would beef up the FDA’s safety regulations, allowing the federal watchdog agency to conduct safety studies of devices after they’ve been approved and to grant conditional approvals contingent on further trials.
U.S. Federal Trade Commissioner J.Thomas Rosch slammed the accountable care organizations instituted by ObamaCare at an antitrust conference yesterday, saying that Medicare cost savings would actually lead to higher overall costs and lower quality patient care.
The ACO initiative aims to shift the business of health care delivery from a fee-for-service model to one that pays hospitals and care providers based on quality of care, coordination of care and cost-effectiveness. It’s slated to kick off on a voluntary basis next year.
Dr. Joseph Gulfo, CEO of Mela Sciences (NSDQ:MELA), says the company plans to begin rolling out its MelaFind skin cancer detection system during the first quarter of 2012, after winning a hard-earned green-light from the FDA.
"I don’t think we’ll be ‘selling,’ in the classic sense of selling, for at least a year and a half," Gulfo told MassDevice. "Dermatologists want this system, so we don’t need to ‘sell’ it.
The FDA is investing $2 million to support innovation centers with the goal of modernizing and improving the way drugs and medical devices are reviewed.
The federal watchdog agency said it will create two Washington, D.C.-based Centers of Excellence in Regulatory Science and Innovation at the University of Maryland and Georgetown University.
FDA officials said it chose to pilot the two centers in the Washington D.C. area to increase face time between the agency’s scientists and university researchers.
A group of congressional democrats from the House Energy & Commerce Committee are urging GOP lawmakers to hold hearings on the safety and regulation of brain stents and metal-on-metal hip implants.
The letter, written by Reps. Henry Waxman (D-Calif.), Frank Pallone (D-N.J.), Diana DeGette (D-Colo.) and John Dingell (D-Mich.) specifically targeted the republican chairmans of three influential House committees.
Most health organizations aren’t ready to protect patient data as access to confidential patient records expands, according to a PricewaterhouseCoopers report.
As new uses for digital patient information grow, according to PwC, health organizations need to step up their act to make sure their patient information doesn’t fall into the wrong hands.
Old privacy and security controls aren’t thorough enough to comply with existing privacy laws and patient consent agreements, according to the report, which recommends that organizations adopt a more integrated approach to protecting patient privacy.
Medical device industry lobby AdvaMed says that the new 2.3 percent excise tax, slated to go into effect in 2013, will be “the last straw on the camel’s back” for medical device companies trying to thrive in the struggling American economy.
The tax puts more than 43,000 U.S. jobs at risk by all but forcing medical device companies to move production offshore to avoid higher taxes, according to the study.
