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Articles from 2008 In May

Neurotech Trade Group Rallying Support for Bill

On its Web site, it has included draft letters and instructions for personalizing them and sending them.

Are Brain-Controlled Prosthetics in Our Future?

Those demonstrated that people could control a cursor on a computer screen with their brain waves, and that monkeys with the sensors could move mechanical arms and legs. But this one is the first to demonstrate that precise control of the prosthetic is possible. The next step is developing a workable wireless system that wouldn't need connections through the scalp.

Institute Issues Alert about Infusion Pumps

There may be no visible indication that a pump permits gravity flow. The institute says that volume testing is the only way to determine whether a particular pump has a door problem, and recommends that users perform such a test immediately, and every three months thereafter.

Medtronic Wins $250 Million in Case Against Boston Scientific

The Fitzmaurice patent involves angioplasty catheters that have narrowed distal ends to aid in delivering the catheter, and the Anderson patent concerns semicompliant angioplasty balloons that can withstand repeated inflations (for custom vessel sizing). Since the jury decided that the infringement was intentional, the judge can raise the award to $750 million. A Medtronic spokesperson said that the company might even seek an injunction to stop the sales of the infringing products.

Device Companies, Investors See Potential in Cut-Free Surgery

They are known as NOTES, which stands for natural orifice transluminal endoscopic surgery. Typically, they involve using the mouth, anus, or vagina as entry points into the body. Early applications are focusing on organ-removal procedures. If NOTES takes off, the procedures would likely be performed with existing endoscopic instruments that have been modified for use with natural orifices. The question yet to be answered is how much these procedures benefit patients. Minimally invasive surgical procedures caught on after years of skepticism because they produced similar or better results as conventional surgeries with much less trauma to the patient. It's not yet clear whether NOTES procedures will bring that kind of substantial improvement. But if they do, a number of companies will be ready to pounce.

Medtronic Pays $75 Million to Settle Charges Against Kyphon

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.

Database System to Help FDA Earlier Identify Issues with Devices

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-company databases. The agency has prepared a white paper explaining how the system will work. UPDATE: Thomas Gross, head of CDRH's division of postmarket surveillance, confirmed that the new system will not bring any extra regulatory requirements upon the device industry.

AdvaMed Praises New Version of Disclosure Bill

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.

Portable Tool Makes Images of Bruises and Tumors

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 sensors that are used in digital cameras. The researchers are looking for collaborators and funding to continue developing the device.

Certain Kinds of Nanotubes May Cause Cancer

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 caused granulomas, which are cellular changes that can lead to cancer. The study will lead to more research, as U.S. regulators do not have much of a handle on how to regulate nanomaterials. It could also lead to follow-up tests and guidance for workers at factories which produce nanotubes, since they are at the highest risk. Labeling to guide consumers and those who handle recycling on proper disposal could be in the cards as well. FDA's task force on nanotechnology did not believe that nanotechnology should change the way medical devices are regulated -- and as alarming as the new study's findings may be, there's no reason to reassess that position. The reason is that medical device materials are already evaluated for toxicity. It is just a matter of taking the new information into account when doing those tests. Expect consumer groups, some of whom already wanted nanomaterials banned from the market until further research was done, to argue otherwise, however, and the mainstream media to print their arguments without questioning them much.