An FDA task force on nanotechnology does not see a need at this time to add more regulations regarding use of nanotechnology in medical devices, but its report recommends that the agency consider developing guidance. It emphasizes that there is a need for ensuring transparent, consistent, and predictable regulatory pathways. Specifically, the task force would like to see guidance that would clarify what information to give FDA about products, and when the use of nanoscale materials may change the regulatory status of particular products. This is the prudent and correct response. At last year's public meeting of the task force, some consumer groups wanted a ban on the use of nanotechnology in FDA-regulated products until more research could be done, or for there to be more regulations controlling...

July 26th, 2007
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A group of healthcare organizations are demanding that FDA require the labeling of PVC devices that contain DEHP. A petition sent by Health Care Without Harm (HCWH) states that exposure to the toxic chemical can cause a disruption in the development of the male reproductive tract, along with harming vulnerable patients such as those on dialysis. For years there has been a debate about whether or not DEHP is harmful. The European Union has already announced mandatory labeling of medical devices that have DEHP, and it currently bans DEHP and other phthalates from toys and cosmetic products. HCWH says that the proper labeling of devices will allow hospitals to switch to safer alternatives. In 2002, FDA issued a warning about the use of DEHP in medical devices, but took no action to enact mandatory labeling.
July 25th, 2007
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The diagnostics industry wants to get in on merger mania, too. Siemens announced that read more >>
July 25th, 2007
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Shares of EV3 Inc. (Plymouth, MN) and FoxHollow Technologies (Redwood City, CA) both surged more than 10% yesterday after the firms announced plans to merge, reports the Star Tribune of Minneapolis. The deal would come to about $780 million. The market capitalization of the two up-and-coming firms would combine for a value of about $1.7 billion, and its annual sales would total about $600 million. EV3 and FoxHollow are both major innovators in endovascular technology, and both firms have been touted highly by Wall Street analysts for years. The company’s combined product portfolio will include atherectomy and thrombectomy devices, PTA balloons, stents, embolic protection devices, infusion catheters and wires, embolic coils and liquid embolics.
July 24th, 2007
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In case you were wondering whether there were more multibillion-dollar deals out there in the device industry, the answer is yes. This morning, reports Bloomberg News, Teleflex Inc. (Limerick, PA) announced it would buy Arrow International Inc. (Reading, PA) for $2 billion. Arrow makes a variety of catheter-based devices for critical and cardiac care. Multi-industry conglomerate Teleflex, which has gone on a huge acquisition binge this year, is offering $45.20 per share, about 20% more than Arrow's closing stock price on Friday.
July 23rd, 2007
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The Star Tribune is reporting that Medtronic Inc. has reached a settlement to end more than 1400 lawsuits related to alleged defects in its defibrillators. The company will be paying more than $75 million as part of the settlement, which is also dependent upon Medtronic's ability to get 90% of the claimants to sign the agreement, the article notes. The claims against the company reportedly said that Medtronic hid battery defects in its defibrillators.  As noted in the blog earlier this week, Boston Scientific agreed to pay $195 million to settle a class-action lawsuit related to Guidant's defective defibrillators.
July 20th, 2007
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A House of Representatives committee approved a patent-reform bill that is opposed by the drug industry but supported by most high-tech industries. That leaves the medical device industry in an odd position, though industry lawyers have encouraged it to side with the drug industry. The bill sets up a way to re-evaluate patents once they are granted. Their validity could be challenged without going through a lengthy court process. That makes sense for high-tech products, which, according to an Associated Press report, "may include hundreds of patented components, [so] industry groups say they are easy targets for patent infringement suits based on inadvertent or minor violations." It does not make sense for pharmaceuticals, which may have only one or two patents at their core. The bill could weaken their patents and create a disincentive to spend money on R...
July 19th, 2007
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Boston Globe columnist Steven Syre has a piece today about the sharp reversal of fortune for the drug-eluting stent businesses of Johnson...
July 19th, 2007
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FDA announced that it has approved the first artificial cervical disc for the treatment of cervical degenerative disc disease. This disease is a significant cause of neck and arm pain. The Prestige Cervical Disc is made by Medtronic Sofamor Danek. Currently, if a patient has a diseased or bulging disc in the neck, that disc is removed and two or more neck vertebrae are fused. The Prestige replaces the damaged disc and is attached to the adjacent vertebrae with bone screws. As with artificial discs for the back, the Prestige offers patients a greater range of motion than they would have with fusion. A post-approval study is required as a condition of approval. The bigger challenge will come with CMS. Artificial spinal disc makers have had trouble getting coverage from CMS. Will the same problem face the Prestige? UPDATE: A second Medtronic cervical disc, the Bryan,...
July 18th, 2007
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Transforming FDA LogoAccording to an Associated Press report, some members of Congress are upset that FDA has increased spending on bonus payments to retain certain employees, especially reviewers. Well, too bad. There's a reason why these bonuses are needed. Without them, the agency would be severely lacking in expertise. The private sector offers much better pay than the public sector, which means reviewers and other personnel are always at risk of crossing over to work for industry. It also means the top scientists and engineers coming out of school aren't exactly chomping at the bit to work for the agency, either. If Congress...
July 17th, 2007
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