Regulatory: Page 260

CMS finalizes coverage for carotid artery stenting

By AuntMinnie.com staff writers

The U.S. Centers for Medicare and Medicaid Services (CMS) has expanded coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery with stenting. The final national coverage determination (NCD) applies to Medicare-eligible participants of a Food and Drug Administration-mandated postapproval study for a newly approved carotid stent.

October 12, 2004

MQSA reauthorized by U.S. Congress

By AuntMinnie.com staff writers

The House of Representatives passed the Mammography Quality Standards Reauthorization Act of 2004 (H.R. 4555) last week.

October 11, 2004

Stentor gets FDA approval for digital mammo

By AuntMinnie.com staff writers

Image management firm Stentor reported that the Food and Drug Administration has given clearance to the company's iSite PACS for use in the diagnostic reading, enterprise distribution, and archiving of digital mammography images.

October 7, 2004

Final 510(k) decisions for September 2004

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 September 2004:

October 5, 2004

Cook gets nod for AAA graft

By AuntMinnie.com staff writers

Interventional technology developer Cook has received Food and Drug Administration (FDA) clearance for its Zenith Flex AAA endovascular graft and H&L-B One-Shot introduction system.

October 3, 2004

Preparation key to surviving MQSA inspections

By Erik L. Ridley

PHILADELPHIA - Inspections to measure compliance with the Mammography Quality Standards Act (MQSA) can be stressful, but proper preparation can alleviate much of the anxiety, according to Bonnie Rush, president of Breast Imaging Specialists (BIS) in San Diego.

October 3, 2004