Other Headlines
Have News for Us?
Submit your news on the industry, people, or companies.
Forward to a FriendMore Industry Headlines
ACR Lines Up to Accredit Imaging Centers Under New CMS Rules The American College of Radiology announced it will be among the first to apply for authority to accredit freestanding diagnostic imaging centers as required by new CMS rules.
Swine Flu Resources Get helpful sites and dashboards to track the spread of the disease and access health information and services.
Shock Wave Therapy Helps Bones Mend Broken long bones that aren't healing could be patched up by shock waves.
Freestanding Imaging Centers Slammed by CMS Ruling The announcement of the final rules by CMS, believed to slash imaging reimbursements by 16 percent, could result in mass closings of rural clinics, according to the American College of Radiology.
Analysts See Big Growth in Devices That Make Home Treatments Easier Needle-less, pain-free and home drug delivery devices to show growth in the parenteral market, according to analysts.
Researchers Check Suspicious Looking Mole (Rat) Pint-sized creature proves an interesting riddle.
FTC Extends Enforcement Deadline for Red Flags Rule Enforcement is scheduled to begin June 2010.
Rad Groups Recommend Keeping a Closer Eye on CT Scan Dosage Protocols After Cedars-Sinai Fiasco In the wake of accidental radiation overexposure of hundreds of patients at a Los Angeles hospital, two leading radiologists groups offer guidelines for making sure patients are getting safe scans.
Stereotactic Radiotherapy Halts Lung Cancer in Patients Too Sick for Surgery A recent study presented at this year's ASTRO annual meeting shows that stereotactic body radiation therapy (SBRT) can kill lung cancer tumors and keep them from recurring in medically frail patients ineligible for surgery.
DOTmed Certified Parts Vendor Program Gains Traction A new and better way for Biomedical Engineers to source parts.
complying appropriately
with the DOJ request
Medtronic Receives Subpoena From U.S. Justice Department
He also said that the investigation was "very focused" on Infuse, and he didn't know if it would be broadened. It was not a surprise to Hawkins that Medtronic, the world's largest medical device maker received the subpoena on the subject, given "stepped-up efforts in general on the topic of off-label use of drugs and devices."
Doctors are free to prescribe drugs for uses not approved by federal regulators or to use devices as they see fit. But pharmaceutical and medical device companies are prohibited by law from marketing for those uses.
Medtronic has said it does not pay surgeons to promote Infuse for unapproved uses. Company spokesman Chuck Grothaus reaffirmed that but said Medtronic would not elaborate on the subpoena.
In 2006 Medtronic reached a $40 million settlement with the U.S. Department of Justice to settle charges that it paid physicians millions in kickbacks to use its spinal repair products. Medtronic denied any wrongdoing.
As part of the arrangement, the government agreed to seek dismissal of the two cases brought by former employees in U.S. District Court in Memphis, where the company's spinal division has offices.
The Infuse graft uses a man-made version of a human protein to encourage bone growth. The Food and Drug Administration approved the system to fuse parts of the spine together during lower-back surgery as well as for oral and dental procedures.
However, serious complications have been reported when the graft is used for alternate uses. In July the FDA warned doctors that use of Infuse for neck surgeries has led to problems swallowing, breathing and speaking, which in some cases required additional surgeries.
Interested in Medical Industry News?
Subscribe to DOTmed's weekly news email and always be informed.
Click here, it takes just 30 seconds.
|
Please Send us your Comments. |
|
|
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2009 DOTmed.com, Inc.
ALL RIGHTS RESERVED
