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Articles from 2007 In July

Combination Device Could Treat Genetic Diseases

The two companies have been collaborating since 2005 on research leading up to the development of the technology. Huntington's is a devastating degenerative disease that causes the deterioration of certain nerve cells in the brain. If the technology is successful in treating this disease, it's possible that Medtronic and Alnylam will develop similar combination devices to treat neurodegenerative disorders such as Parkinson's.

Baxter Recalls Infusion Pumps Over Faulty Service Records

That means it is possible that some pumps sent away for service that patients believed were fixed in fact weren't. Patients are advised to return affected pumps to Baxter for repeat servicing. The models affected are Baxter Colleague and Flo-Gard volumetric infusion pumps, model numbers 2M8151 and 2M8153, Colleague CX volumetric infusion pumps, model numbers 2M8161 and 2M8163, and Flo-Gard volumetric infusion pumps, model numbers 2M8063 and 2M8064.

Medtronic Buys Kyphon

Months ago, Medtronic CEO Art Collins said that the company's growth was dependent upon having a diverse line of products. Once the acquisition is completed, Medtronic will also drop the lawsuit it filed against Kyphon over four patents involving catheters and spinal treatments.

NFL Team Using CT Scans to Assess Head Injury

NeuroLogica Corp's (Danvers, MA) CereTom scanner instantly generates images of the neck and head in minutes to help diagnose brain injuries and bleeding. It can also reveal injuries to the elbows, knees, and ankles. After the scan is completed, it can be wirelessly transmitted to a doctor for diagnosis. As a side note, the NFL formed a traumatic brain injury committee and announced earlier this year that it's planning on looking at the potential link between concussions and depression in players.

FDA May Develop Nanotech Guidance

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 nanotechnology's use. But in the case of devices, the PMA and 510(k) processes already require information about what a device is made of, so FDA already has the authority to make device companies perform toxicology and other tests and provide data showing nanomaterials are safe. What industry needs is clarification about how this process should work, not a new process. And that's what the guidances are for.

Groups Petition FDA to Label Devices Containing DEHP

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.

Siemens to Pay $7 Billion for Dade Behring

Dade Behring's specialties include routine chemistry testing, immunodiagnostics, hemostasis testing and microbiology. This is the third major diagnostics acquisition Siemens has made recently. Last year it acquired Bayer Diagnostics and Diagnostics Products Corp. The goal, Siemens says, is to "become the global leader in full-service diagnostics, offering imaging diagnostics, clinical laboratory diagnostics and healthcare IT solutions - from a single source and along the entire value chain." Without resorting to bribery, presumably. This again raises the question of who will buy Abbott's diagnostics business now that GE doesn't want it. Siemens, with all its other acquisitions, wouldn't seem to be a player for it either, and there aren't many other diagnostics firms with the size to pull it off.

Wall Street Loves EV3-FoxHollow Merger

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 companyâEUR(TM)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.

Teleflex to Buy Arrow for $2 Billion

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.

Medtronic Next in Settling Defibrillator Suits

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.