Regulatory: Page 287

SonoSite gets regulatory clearance in Japan
By AuntMinnie.com staff writers
Handheld-ultrasound provider SonoSite of Bothell, WA, has received clearance from the Japanese Ministry of Health, Labor, and Welfare to market and distribute its 180Plus and SonoHeart Plus ultrasound systems.
January 15, 2002
U.S. gives thumbs-down on PET for Alzheimer's
By AuntMinnie.com staff writers
The nuclear medicine community may be convinced of PET's value in diagnosing Alzheimer's disease (AD), but the U.S. government isn't sure enough to pay for it. On Thursday a Medicare panel recommended that the Centers for Medicare and Medicaid Services not cover use of FDG-PET in the diagnosis and management of the disorder.
January 10, 2002
HIPAA extension becomes law
By AuntMinnie.com staff writers
A one-year extension to the standard transactions and code set requirements of the Health Insurance Portability and Accountability Act.
January 9, 2002
CMS tackles FDG-PET reimbursement for Alzheimer’s
By AuntMinnie.com staff writers
The diagnostic imaging panel of the Center for Medicare and Medicaid Services (CMS) will hold a hearing today on PET and Alzheimer’s disease.
January 9, 2002
Final 510(k) approvals for December 2001
Issued January 7, 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 December 2001.
January 7, 2002
CMS postpones 2002 HOPPS rates pending review
By AuntMinnie.com staff writers
The Centers for Medicare & Medicaid Services is postponing its 2002 hospital outpatient prospective payment system (HOPPS) rates, pending a review by the U.S. agency.
December 18, 2001
IMS wins FDA approval for Giotto Image
By AuntMinnie.com staff writers
Italian medical imaging vendor IMS has received 510(k) clearance for the newest version of its Giotto line of mammography units.
December 18, 2001
FDA clears Imagyn brachytherapy system
By AuntMinnie.com staff writers
Medical device manufacturer Imagyn Medical Technologies has received 510(k) clearance from the FDA to market its isosleeve pre-loaded needle delivery system for prostate brachytherapy.
December 5, 2001
CPT codes issued for RF ablation of liver tumors
By AuntMinnie.com staff writers
The American Medical Association has issued current procedural terminology (CPT) codes for the radiofrequency (RF) ablation of liver tumors in the latest edition of its official coding reference.
December 5, 2001
PET payment cut will force efficiency, procedure volume gains
By Erik L. Ridley
Last week the U.S. Centers for Medicare and Medicaid Services (CMS) cut FDG-PET reimbursement from $2,331.18 to $1,375. The decision was disappointing, but it could have been worse, PET advocates say.
December 5, 2001
Final 510(k) approvals for November 2001
Issued December 5, 2001
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 2001.
December 4, 2001
U.S. House passes HIPAA extension
By Eric Barnes
To the relief of harried healthcare administrators, the U.S. House of Representatives voted Tuesday night to postpone implementation of some provisions of the Health Insurance Portability and Accountability Act (HIPAA). If the Senate concurs, the bill will delay the advent of transaction and code set standards until 2003.
December 4, 2001
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