Janet Moore gets it. It is all too common for industry to be completely left out of mainstream media pieces on medical innovations. Such stories often focus on the doctor and patient perspective and don't mention that without a company's R...
March 14th, 2007
0
Boston Scientific may spin off its endosurgery unit, though it would retain control of the business, reports the Boston Globe. The firm's board is looking in to an initial public offering that would sell 20% of the endosurgery group, which would get its own name and corporate identity, to the public. Boston Scientific would retain control of the other 80%. The deal would be patterned after Nestle's 2002 spinoff of its Alcon eyecare business, in which the conglomerate raised $2 billion yet retained control of almost 77% of Alcon. Boston Scientific CEO Jim Tobin thinks the endovascular business is undervalued and that the partial IPO would rectify that. Given the controversies surrounding the products Boston Scientific inherited from Guidant and its own flagship product, the Taxus drug-eluting stent, he's probably right. Is this an admission by management that the...
March 13th, 2007
0
When an FDA advisory panel convened in December to discuss safety issues of drug-eluting stents, many observers felt some sort of regulatory action would result. It has, but not in the way most expected. The biggest revelation from the meeting, which may become its most significant legacy, was the extent that stents are used off-label. That prompted Congress to begin an investigation into how they are promoted. And now, FDA is expanding a campaign to stop the promotion of stents for unapproved uses, reports Bloomberg News. Agency officials met yesterday with makers of heart and bile-duct stents to remind them of its guidelines about off-label promotion, most of which is not allowed.
March 13th, 2007
0
British orthopedics giant Smith & Nephew plc is continuing its aggressive growth strategy. It has announced plans to buy Swiss ortho player Plus Orthopedics Holding AG for $889 million in cash, including assumed debt. This should boost Smith & Nephew's share in the orthopedic reconstruction market, especially in Europe. Plus primarily makes artificial hips and knees and has plants in Switzerland and China, both of which were coveted by Smith & Nephew. Smith & Nephew has made several acquisitions in the past year, and a few months ago made an unsuccessful play for American rival Biomet.
March 12th, 2007
0
A professor at Purdue University not only recognizes the AIDS epidemic in Africa--he's doing something about it. In an extensive project that involves discussions with groups around the world, Paul Robinson, a professor at Purdue's schools of biomedical engineering and veterinary medicine, has taken the reins to develop a low-cost technology that will be used to perform medical testing on people with AIDS in Africa. The test detects CD4 cells, the cell count that provides the therapeutic monitoring of AIDS. Robinson and Gary Durack, president of iCyt, established Cytometry for Life, a program that is aiming to manufacture and deliver the low-cost devices to the most resource-poor countries. The cost of a CD4 test in Africa runs about $10 per patient. Robinson and Durack are aiming to build a device that can perform the test for about 50 cents per patient. Robinson told MD...
March 9th, 2007
0
A research team at Ritsumeikan University in Japan has developed a prototype of a miniature robot that could be inserted into the body to perform medical procedures, reports Agence France-Presse. It weighs 5 g and measures 2 cm in length. It includes sensors, a camera, and a drug-delivery injector. It will surely be a while before we see this technology commercialized, but it seems to have great potential.
March 8th, 2007
0
A bill to modernize Medicare's reimbursement system for diagnostic tests was reintroduced into the House this week, with strong support from AdvaMed. The Medicare Advanced Laboratory Diagnostics Act would, among other things, foster the creation of a new payment system for molecular diagnostics, provide more transparency on reimbursement decisions, timely correct payment errors, and improve processes for adequate reimbursement of new tests. AdvaMed and the bill's bipartisan supporters claim that the current Medicare system does not recognize the value of genetic-based tests and provides a disincentive to develop new tests. The bill was first introduced in May 2006 but did not get anywhere then.
March 7th, 2007
0
The House Committee on Oversight and Government Reform has subpoenaed documents from Boston Scientific and Johnson...
March 6th, 2007
0
Transforming FDA LogoAs of this morning, details of the MDUFMA reauthorization agreement between FDA, Congress, and industry had not yet been released, but AdvaMed president Stephen Ubl shed some light on them at last week's American Institute for Medical and Biological Engineering annual meeting. He shared three points: 1. "We are reducing fees across the board for applications -- whether PMAs or 510(k)s." 2. "The year-to-year increases will be more predictable. There will be no more compensation adjustment, which made the system more volatile." 3. "We estimate that the new goals will bring performance improvements for FDA reviewers and significantly reduce review times." He also noted that "other...
March 5th, 2007
0
Daylight Savings Time gets longer this year. A federal law passed in 2005 extending it by four weeks in order to save energy goes into effect this month. That means it will begin on March 11 instead of April 1, and end on November 4 instead of October 28. However, medical devices and related equipment may not have the new information programmed in, and FDA is concerned about whether that will affect functionality. It has put out an advisory to caregivers and hospital personnel and one to patients to make them aware of potential problems. Device manufacturers may be getting a lot of calls about this over the next nine days.
March 2nd, 2007
0