The device industry and its backers have made lots of money off minimally invasive surgery in the past 20 years. It is no surprise, then, that there would be a lot of interest in the next frontier: read more >>
May 27th, 2008
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FDA today unveiled the Sentinel System, a series of databases that will allow it to query a broad array of information to identify possible post-market adverse events. Rather than waiting for adverse-event reports to trickle in, the agency will now be able to proactively search databases and look for problematic patterns of side effects and adverse events. If the system works as envisioned, the agency would be able to identify problems and alert doctors and patients to them much more quickly than it can now. This could prevent adverse events and save costs. No patient-specific data will be returned in the searches, so privacy issues should not be a concern. The effort will begin with a pilot program, using CMS's Medicare Part D database. Eventually, FDA will also be able to search other CMS databases, and databases from the private sector -- such as electronic medical records in hospital systems, and insurance-...
May 22nd, 2008
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Medtronic announced that it has reached an agreement with the Department of Justice to settle a "qui tam" case against Kyphon, which it bought in November 2007, for $75 million. The case against Kyphon concerned improper reimbursement advice it gave to customers regarding kyphoplasty procedures. The company also assented to a Corporate Integrity Agreement in which employees will be trained on how to give appropriate reimbursement advice and the firm will set up and maintain compliance procedures. Medtronic said it knew about the pending settlement when it acquired Kyphon, and Kyphon had already accounted for it. DeviceTalk will return on Tuesday, May 27.
May 22nd, 2008
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AdvaMed said it supports the changes recently made to a Senate bill on disclosure to patients of doctors' financial ties to drug and device companies. "This bill is an important step forward in improving transparency and does so in a manner that does not jeopardize future innovation. That’s good news for patients, physicians and industry," said Stephen J. Ubl, president and CEO of AdvaMed. The modifications include preemption of state disclosure laws to ensure consistency; requiring compliance by physician-owned manufacturers, distributors, and group purchasing organizations; and requiring disclosure information to be displayed in an easy-to-understand manner. AdvaMed would like to see one more change: exempting companies who pay less than $250,000 per year to physicians.
May 22nd, 2008
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Georgia Tech researchers have designed an imaging tool that could help clinicians spot the severity of bruises at the point-of-care. It also has potential in diagnosing early stage tumors and cancer. The narrowband filter mosaic is a single-exposure device that would be used for multispectral imaging to provide subsurface characterization. Clinicians who use the device would be able to detect and evaluate how bad bruises and erythema are in real time, which can sometimes be a challenge in patients who have darker skin pigmentation. Better imaging will offer earlier detection of erythema, which could help stop the progression of pressure ulcers. It also has implications for earlier intervention in suspected cases of physical abuse. The wallet-sized device has a filter that works at four or more wavelengths from visual to infrared, with 20-nm bandwidth in a single exposure. It can be laminated with the same imaging...
May 22nd, 2008
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Certain kinds of carbon nanotubes triggered a cellular reaction in mice similar to that which leads to mesothelioma, a form of cancer, a study published in the online version of the journal Nature Nanotechnology reports. Nanotubes are used in a variety of consumer products, and some medical devices. This means that these materials will need to be handled very carefully, reports the Washington Post. The findings do not apply to all nanotubes, nor do they necessarily predict effects on humans. And they are based on a small sample size. The effects were found only on the longest versions of nanotubes. And the mice were injected with the nanotubes, whereas humans would come into contact with them by inhaling them. The injections were made into the tissue around the lungs, and the longer nanotubes...
May 21st, 2008
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A radiofrequency ablation system that can help prevent esophogeal cancer is drawing much attention at a gastroenterology conference, and from the Wall Street Journal. But if you've been reading MD...
May 20th, 2008
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Two shareholders of stock in CryoCor Inc. who say they represent a class action have sued the company, its directors, and Boston Scientific, its potential buyer, in California court to block the sale of the company announced last month. The suit alleges that both companies breached their fiduciary duties to shareholders when the $17.2 million deal was agreed to. It wants the deal blocked but, if that is not possible, it wants the firms to pay compensation to shareholders. CryoCor management says it will fight the suit, which it believes is without merit. CryoCor makes a disposable catheter system based on cryoablation technology. UPDATE: The transaction was completed on May 28. Boston Scientific did not comment on the lawsuit.
May 19th, 2008
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Nestled between Los Angeles and San Diego, Orange County, CA has long been a hotbed of medical device companies. The New York Times has taken notice that read more >>
May 16th, 2008
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Patients with implanted heart devices need closer follow-up care than they are currently getting, experts on a panel at the Heart Rhythm Society meeting said yesterday. They have written the first guidelines on this matter, reports the Associated Press. More than 2 million patients worldwide have implantable devices that help their hearts beat faster, slower, or more regularly. The guidelines include advice on when to turn a device off and let a patient die, and how to make sure that more complex devices are maintained. They also endorse remote monitoring. The Cleveland Clinic produced data to support the latter position. It found that over five years, 5,000 of its patients moved to remote monitoring, but the burden on hospital personnel was minimal.
May 15th, 2008
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