Regulatory: Page 281

The return of the SalaryScan Survey
By Brian Casey
AuntMinnie's CompHealth SalaryScan Survey is back! That’s right -- we're collecting data once again to update our popular SalaryScan compensation comparison tool.
December 19, 2002
Guidant gets CE Mark for stent system
By AuntMinnie.com staff writers
Interventional device firm Guidant has received CE Mark approval for its Multi-Link Vision coronary stent system, a cobalt-chromium alloy stent for the treatment of coronary artery disease.
December 18, 2002
Final PMA Approvals for November 2002
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of premarket approvals (PMA), product development protocols (PDP), supplement and notice decisions from the previous month. The following decisions were rendered for November 2002.
December 4, 2002
Quantum gets C-arm 510(k) clearance
By AuntMinnie.com staff writers
Radiography developer Quantum Medical Imaging has received Food and Drug Administration 510(k) clearance for an integrated C-arm called the QV-800 Universal System. The product is designed as a single-panel digital receptor for use within a hospital’s trauma unit.
November 26, 2002
Analogic, IMS form FFDM alliance
By AuntMinnie.com staff writers
Peabody, MA-based imaging equipment vendor Analogic has joined forces with Internazionale Medico Scientifica (IMS) of Bologna, Italy in a five-year strategic alliance for the exchange of mammography product and technology information.
November 26, 2002
Bracco gets approvable letter for MultiHance
By AuntMinnie.com staff writers
Contrast developer Bracco Diagnostics of Princeton, NJ, has received an approvable letter from the Food and Drug Administration for its MultiHance MRI contrast agent.
November 24, 2002
Nucletron product gets FDA 510(k) clearance
By AuntMinnie.com staff writers
Dutch radiation therapy firm Nucletron has gained U.S. Food and Drug Administration 510(k) clearance for its Spot Pro 3-D ultrasound planning system for all seed-implant techniques.
November 19, 2002
CMS to maintain PET payment rates
By Kate Madden Yee
PET proponents are rejoicing at the news that the Centers for Medicare and Medicaid Services (CMS) will retain 2002 outpatient reimbursement rates for FDG-PET procedures next year. CMS had been proposing a 42% cut in the rate for oncology PET procedures and a 9% cut in cardiac PET payments for its 2003 outpatient payment schedule.
November 7, 2002
Final 510(k) decisions for November 2002
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for November 2002.
November 5, 2002
Medicare boosts outpatient mammography and colonoscopy payment rates
By AuntMinnie.com staff writers
Under a final rule from the Centers for Medicare and Medicaid Services (CMS), Medicare payments for hospital outpatient procedures will increase in 2003 by almost 6%. Payments for diagnostic mammography and colonoscopy will increase 11% and 10%, respectively.
November 4, 2002
Complications Related to the use of Bone Cement in Vertebroplasty and Kyphoplasty
Issued October 31, 2002
The Center for Devices and Radiological Health, Food and Drug Administration has posted a new Web notification, "Complications Related to the Use of Bone Cement in Vertebroplasty and Kyphoplasty Procedures."
October 30, 2002
Boston Scientific biliary stent approved
By AuntMinnie.com staff writers
The Food and Drug Administration has given Boston Scientific of Natick, MA, clearance to market its biliary stent system.
October 29, 2002
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