FDA Commissioner Andrew von Eschenbach admitted to Congress that the dispute over TMJ Implants’ appeal of a warning letter was “a process failure,” and said the agency is currently reviewing its procedures for handling disputes and appeals of warning letters, HealthImaging.com reports. An assistant commissioner is leading the review. The commissioner said FDA staff will follow up with the House Oversight and Investigations Subcommittee staff when the new procedures are in place.
Reps. Dan Barton (R-TX) and John Shimkus (R-IL) sent an angry letter to von Eschenbach last month over the treatment of TMJ Implants. CDRH issued a warning letter to the firm for not filing 17 Medical Device Reports, but the company disputed that MDRs were warranted. The firm says its appeal was never substantively reviewed before an FDA administrative law judge ruled against it and ordered it to pay $630,000 in fines.
May 9th, 2008
A gene-based urine test could provide a more specific diagnosis of prostate cancer than the PSA test. The test, developed by Gen-Probe, examines the PCA3 (prostate cancer gene 3) score. According to a study published in the May issue of Journal of Urology, the PCA3 could be the most successful measure to detect the stage and grade of prostate cancer. It’s possible that doctors could use Gen-Probe’s test, PROGENSA, to actively monitor tumor growth before aggressive and invasive treatment is explored. This could be an especially useful tool in cases of older cancer patients, where many doctors opt for a wait-and-see approach. The study also found a connection between the PCA3 score and tumor volume, and that the PCA3 score was the best predictor of tumor volume when compared with other measures.
May 9th, 2008
Members of the House and Senate have introduced the National Neurotechnology Initiative (NNTI) Act, which would increase federal funding by $200 million for treatments of brain-related injuries, illnesses, and diseases. It would also make improvements to how the federal government coordinates research in this area, bringing together efforts at the National Institutes of Health, Department of Defense, Veterans Administration, and other entities. The bill includes $30 million for FDA to add neuroscience-related staff and to create workshops on neurotech-related issues. This could increase the timeliness and safety of the review process of neurotech products.
The bill is sponsored by Pete Domenici (R-NM) and Patty Murray (D-WA) in the Senate, and Patrick Kennedy (D-RI) and Ileana Ros-Lehtinen (R-FL) in the House.
May 8th, 2008
Public Citizen’s Health Research Group is asking FDA to force the Ortho-Evra birth-control patch, made by Johnson & Johnson, off the market, Reuters reports. A study released in January found that women aged 18-44 who use the patch are twice as likely to develop a dangerous kind of blood blot than women on birth-control pills. Public Citizen is also concerned that the amount of estrogen released by the patch varies widely among individual women — and estrogen is linked to blood clots.
FDA has said that the risk of the patch causing a blood clot is low, and therefore the product is still considered to be safe and effective when used as directed. It said that for every 10,000 women who use a hormonal contraceptive for one year, 3-5 will develop a blood clot.
May 8th, 2008
Medtronic announced that it will cut about 1100 jobs, or almost 3% of its work force, from slow-growing businesses as part of a global realignment, Reuters reports. Some of the cuts will come from the firm’s flagship business, cardiac rhythm management. Partly because of reduced demand exacerbated by high-profile recalls in the sector, it grew 3% last quarter, compared to 12% for the company overall. Also as part of the restructuring, the diagnostic and monitoring portion of the CRM business will move from the Netherlands to Minneapolis, and the firm’s endovascular manufacturing operations will move from Santa Rosa, CA to Galway, Ireland. Some fast-growing businesses will add jobs. The move follows a series of cuts last year that eliminated 900 jobs, and some management changes, including the departure of the COO, announced last week.
May 7th, 2008
Some members of Congress have expressed concern about Medicare’s competitive-bidding program for providers of devices like wheelchairs and oxygen tanks. Hearings are being scheduled, reports the Wall Street Journal. Lawmakers of both parties have responded to device companies’ concerns that the bidding process is flawed and that the program could put some smaller providers out of business. At least one consumer group believes that the program may decrease quality and access of care for patients. But Medicare says it needs programs like this in order to cut costs. Expect this kind of battle to play out often during the coming years.
A month ago, a federal judge killed Medicare’s competitive-bidding program for clinical laboratories. Perhaps critics of competitive-bidding programs felt empowered after that.
May 6th, 2008
Almost two years after GE Healthcare Surgery closed a Salt Lake City plant because of quality issues, the firm has reopened the plant, the New York Times reports. FDA gave the OK yesterday after GE demonstrated that it had made “refinements” to its quality management system. GE voluntarily closed the plant in August 2006 and entered into a consent decree with FDA in January 2007, barring it from shipping X-ray equipment from that plant until the problems were solved. What was amazing about the closure was that it happened because of basic QSR violations that one would have thought a large, experienced firm would have known to avoid.
The production lines are already up and running, and product could be shipped out in as soon as 10 days. The closure had a significant impact on the bottom line of GE’s healthcare division.
May 6th, 2008
Drug giant Bristol-Myers Squibb is selling off its ConvaTec wound therapy and surgical care unit for $4.1 billion, reports the Associated Press. The buyers are two private equity firms, Nordic Capital and Avista Capital Partners. The firm, like most of the other drug giants who bought up device firms in the 1980s, has decided to divest itself of devices and devote more resources to biopharmaceuticals. It sold off a medical imaging unit last year.
May 5th, 2008
Sunday’s New York Times had a lengthy profile of Frederic Moll, the Bill Gates of surgical robotics. Moll founded the market leader, Intuitive Surgical, and these days runs Hansen Medical and Restoration Robotics. He is also on the board of Mako Surgical. Some interesting tidbits:
* Moll was not driven by a desire to use robotics, but by a desire to make surgery less invasive. When he saw early designs of surgical robots, he became convinced that they could help in that area.
* In 1994, Moll pitched the business plan that became Intuitive Surgical to his then-employer, Guidant. The company rejected it, and a year later Moll rounded up investors and struck out on his own. Imagine how Guidant’s fortunes might have been altered had it approved Moll’s plan.
* Moll sees the greatest value of robots as their ability to make average surgeons perform as well as world-class ones. “The public has no idea of the extent of difference between top surgeons and bad ones,” he told the Times. “Robots are good at going where they are supposed to, remembering where they are and stopping when required.”
The piece also mentions two surgical robotics firms not affiliated with Moll, Accuray and Stereotaxis.
Some of those interviewed for the article question whether hospitals will ever see much of a return on investment from surgical robotic systems. But it appears many top hospitals see them not as a profit-maker but as a means by which to recruit top surgeons. And Wall Street remains bullish. The share price of Intuitive, which was named one of MD&DI’s Medical Manufacturers of the Year in 2007, has increased almost sevenfold in the last three years. And Hansen was able to raise $39.4 million earlier this year, despite the gloomy outlook on the economy. So for now, anyway, the sector’s stunning growth should continue.
May 5th, 2008
Electrosurgical product manufacturer Bovie Medical Corp. (Melville, NY) is acquiring radio frequency technology from Boston Scientific. The deal involves the technology, patents, and assets related to using conductive sintered steel as an electrode for RF cutting and coagulation. The technology aims to decrease blood loss, save hospitals money, and speed up procedure times. It can be used for tumor therapy in the lever, pancreas, and kidneys, as well as for orthopedic and blood vessel sealing. Bovie gave Boston Scientific a license to use the technology outside of the fields mentioned above until 2016.
May 2nd, 2008
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