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The Medical Industry Business Weekly |
| August 28, 2008 |
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Other HeadlinesCompany warns hospitals about unvalidated FirstCall probe files.
UnitedHealth Group of Minneapolis extends imaging accreditation deadline to the fourth quarter of 2009.
CMS releases guide to improve access to navigating Medicare requirements for approving innovative technologies.
Group of organizations discussed radiation dose used in scans performed on children at recent gathering.
With today's technology and treatments, doctors can find and fix osteoporosis.
Have News for Us?Submit your news on the industry, people, or companies.More Industry HeadlinesSonora Medical Systems Warns of Illegal Software Modifications Company warns hospitals about unvalidated FirstCall probe files. Imaging Accreditation Deadline Extended by UnitedHealth Group UnitedHealth Group of Minneapolis extends imaging accreditation deadline to the fourth quarter of 2009. Medicare May Approve Advanced Technologies Faster CMS releases guide to improve access to navigating Medicare requirements for approving innovative technologies. Alliance for Radiation Safety in Pediatric Imaging Held Pediatric CT Vendor Summit Group of organizations discussed radiation dose used in scans performed on children at recent gathering.
LAST CHANCE -- PHILIPS Duo Diagnost Remote R/F Room So get your bids in early this week...if you "snooze," you could "lose" out on a great deal on just the system you want! Doctors Get Treatment Right the First Time With a Virtual Heart Doctors could soon be able to perform minimally invasive surgery on virtual versions of people's hearts to help ensure they make the best decisions for their patients before doing the procedure for real. AMA Concerned: New ICD-10 Proposed Rule a Burden for Physicians Physicians' group worries about administrative burden of proposed reimbursement coding system. FDA, EMEA Will Consider Additional Toxicity Tests in Reviewing Drug Safety New joint effort might result in better detection of cellular damage. Abbott Laboratories Will Eliminate Approximately 1,000 Jobs Abbott Laboratories Inc. will eliminate about 1,000 jobs over the next four years as part of a plan to streamline operations and cut costs in its medical diagnostics business. GE Healthcare and Hologic Talk About Fan Beam Technology OEM briefings on the latest bone densitometry innovations. 
bone morphogenetic
protein Warning by FDA About Bone Growth Products Made by Medtronic, Inc. and Stryker Corp.by Joan Trombetti, Writer
The U.S. Food and Drug Administration warned that bone growth products made by Medtronic, Inc. and Stryker Corp. have been linked to life-threatening complications when used without approval in neck fusion surgeries.
The FDA reported it has received at least 38 complaints in the last four years of neck swelling and breathing problems in patients given the products, which are not FDA-cleared for use in the neck. Medtronic and Stryker make types of recombinant human bone morphogenetic proteins used to help treat degenerative disc disease, fractures and other bone conditions. InFuse Bone Graft by Medtronic and OP-1 Implant and OP-1 Putty by Stryker both contain such protein. Daniel Schultz, head of the FDA's device center, said it was not clear what caused the complications or whether certain patients were at greater risk. He said the neck's close proximity to critical airways was part of the problem. In some cases, patients had to have a tube inserted to help them breathe or had to have a tracheotomy. Others were given medications or underwent further surgery. Most of the complications arose between two days and two weeks after surgery, Schultz said in a letter to doctors posted on the agency's website. In response to the FDA notice, Stryker Corporation responded, "OP-1 is not indicated for use as a bone graft substitute in the cervical spine and healthcare professionals should follow the approved clinical indication for this and all of our products." 
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