by
Brendon Nafziger, DOTmed News Associate Editor | December 29, 2011
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3. A shoulder massage device can kill you
If you have the ShoulderFlex Massager, you should throw it out. In fact, you should tear it up before you throw it out so no one else can use it. That was the message given out by the Food and Drug Administration in a recall notice posted in August, after reports surfaced on one person getting strangled by the device. Just the other week, the FDA had to re-post its warning after it discovered that the company that sold the device, King International, went out of business and had not "followed through with recall procedures."
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2. Another MRI-compatible pacemaker in the works
In February, Medtronic Inc.'s Revo MRI SureScan became the first pacemaker conditionally approved by the Food and Drug Administration for use around MRI scanners. Previously, many patients with implanted cardiac devices were unable to get an MRI scan, as the strong magnetic fields could interfere with the implants. Medtronic estimated about 200,000 patients opted out of MRI scans every year because of this. About six months after the product's release, though, the company announced it was working with the FDA to set up a clinical trial for its second-generation MRI-compatible implant, the Advisa DR MRI SureScan. The trial is expected to wrap up by 2013. But if you really want one, as is often the case, they're already available in Europe.
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1. Virtual colonoscopy gets more popular
Screening with CT colongraphy (also called virtual colonoscopy) is not without its critics, and currently Medicare doesn't reimburse it. But diagnostic CTCs (ordered in response to a specific complaint) are often reimbursable, although with Medicare it's subject to regional variations. But that hasn't stopped CTC from spreading. In the most-clicked story of the year, we reported in April that the use of CTC tripled between 2005 and 2008, while reimbursement denials fell. And with only half of the 40 million patients eligible for colorectal screening tests actually undergoing the exams, "the potential for future and dramatic growth of CTC clearly exists," the researchers said.
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